Several standards, regulations, and guidelines outline requirements for implementing a QMS in the manufacturing industry, such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, ICH Q10, Good Manufacturing Practice (GMP), ISO 22716:2007, ISO 22000:2018, ISO/TS 16943:2009, AS9100D, and others.

These requirements support companies operating in manufacturing industries in developing and implementing effective QMS. Manufacturing industries encompass medical devices, pharmaceuticals, cosmetics, food and beverage, automotive, aviation, space, and defense, among other industries.

The standards, regulations, and guidelines outline requirements for essential QMS processes, such as document control, change control, training management, deviation and nonconformance management, CAPA management, audits management, supplier management, and others.

This article will cover what a QMS for manufacturing is, several QMS requirements based on different manufacturing sectors, primary QMS processes, and the role of QMS software for manufacturing companies.

SimplerQMS offers a fully validated eQMS software (according to GAMP 5) designed specifically for Life Science companies. Book a demo to see how SimplerQMS can help you streamline your quality management processes and ensure compliance.

This article covers the following topics in more detail:

• What is a Quality Management System (QMS) for Manufacturing?
• What are the Relevant QMS Requirements for Manufacturing?
• What are the Primary QMS Processes in Manufacturing?
• What is the Role of QMS Software for Manufacturing Companies?

What is a Quality Management System (QMS) for Manufacturing?

A Quality Management System (QMS) for manufacturing is a structured system of policies, processes, procedures, work instructions, and records designed to manage quality throughout the manufacturing lifecycle. Manufacturing QMS aims to ensure that products comply with regulatory and customer requirements.

The purpose of a QMS in the manufacturing industry is to ensure and enhance product quality and reliability and increase process efficiency. The manufacturing QMS helps reduce waste and increase customer satisfaction and business profitability.

Key QMS processes in manufacturing include document control, change management, training management, product management, deviation and nonconformance management, CAPA management, complaint management, audit management, supplier management, risk management, and equipment management, among others.

Traditionally, QMS processes have been managed in a paper-based format, involving manual documentation, physical storage, and in-person audits. The paper-based QMS is time-consuming, prone to errors, and challenging to maintain consistently across large companies.

In contrast, an Electronic Quality Management System (eQMS) offers a digital platform to automate and streamline the management of quality processes. An eQMS provides automated workflows, improves data integrity, facilitates accessibility, and supports compliance.

SimplerQMS provides a comprehensive eQMS solution tailored to meet the specific needs of Life Science companies. SimplerQMS is designed to streamline workflows, improve efficiency, and support compliance with stringent regulatory requirements in the Life Science industries.

Our eQMS provides integrated QMS modules for document control, product management, equipment management, CAPA management, audit management, supplier management, and much more, allowing seamless work.

What are the Relevant QMS Requirements for Manufacturing?

Manufacturing quality management systems are governed by numerous QMS requirements to ensure that products comply with regulatory and customer requirements. Strict requirements for manufacturing are essential to establish and uphold a QMS that ensures uniform and high-quality processes and products.

QMS requirements for manufacturing vary depending on factors such as industry, location, product type, and specific additional requirements.

QMS Requirements for General Manufacturing

The relevant QMS requirement applicable to general manufacturing is ISO 9001:2015.

ISO 9001:2015

ISO 9001:2015 is an international standard that specifies requirements for a quality management system. ISO 9001:2015 enables companies to demonstrate their ability to consistently provide products and services in compliance with customer and regulatory requirements.

Below are six ISO 9001:2015 sections to exemplify the requirements for QMS.

• Documented information
• Operational planning and control
• Management review
• Design and development of products and services
• Monitoring, measurement, analysis, and evaluation
• Improvement

ISO 9001:2015 helps organize a QMS, foster customer and management satisfaction, implement continuous improvement, and reduce costs.

QMS Requirements for Medical Device Manufacturing

Relevant QMS requirements that apply to medical device manufacturing are presented further.

• ISO 13485:2016
• FDA 21 CFR Part 820 (Quality System Regulation – QSR)
• European Union (EU) Regulation 2017/745 (Medical Device Regulation – MDR)
• Good Manufacturing Practice (GMP), including EU GMP, US GMP, WHO GMP, and national GMPs

ISO 13485:2016

ISO 13485:2016 is an international regulatory standard that defines requirements for a quality management system in companies providing medical devices and related services. ISO 13485:2016 is applicable when a company needs to demonstrate the ability to consistently comply with customer and regulatory requirements.

ISO 13485:2016 outlines specific requirements for a QMS in the design, development, production, installation, and servicing of medical devices. The ISO 13485:2016 standard focuses on the safety of the end-user and the efficacy of the medical device.

Having an ISO 13485:2015 compliant QMS helps ensure that medical device manufacturers comply with customer and regulatory requirements and improve product quality and safety.

FDA 21 CFR Part 820 (Quality System Regulation)

FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), is a regulation established by the United States Food and Drug Administration (FDA). The 21 CFR Part 820 defines the requirements for a medical device quality management system.

The 21 CFR part 820 aims to ensure the consistent production and control of medical devices, ensuring the safety and effectiveness of those products.

The 21 CFR Part 820 regulation outlines specific requirements for the design, manufacturing, packaging, labeling, storage, installation, and servicing of medical devices sold or distributed in the United States.

EU Regulation 2017/745 (Medical Device Regulation)

EU regulation 2017/745, the Medical Device Regulation (MDR), is a regulation by the European Union to ensure the safety of end-users and the efficacy of medical devices.

The EU MDR specifies the requirements for medical device design, manufacture, clinical performance, post-market surveillance, and more across EU member states. Having an MDR-compliant quality management system helps ensure compliance with the requirements for medical device manufacturing, improving product safety and quality while reducing the risk of non-compliance.

The MDR Article 10 outlines the general obligations of QMS manufacturers in the medical device industry, including product realization, reporting of serious incidents, and risk management, among others.

Good Manufacturing Practice (GMP) for Medical Device Manufacturing

Good Manufacturing Practices (GMP) are regulations, standards, and guidelines designed to ensure the uniform and high-quality production and control of products.

GMPs are established by various governments and organizations, such as the European Union and the World Health Organization (WHO). Fortunately, these GMP standards are highly similar.

GMP covers various aspects of manufacturing, including cleanliness, equipment verification, process validation, and documentation. A QMS must meet GMP requirements to enable companies to achieve and maintain product quality and safety.

Examples of GMP standards include US GMP, EU GMP, and WHO GMP, among others.

US GMP for Medical Device Manufacturing

US GMP stands for the United States Good Manufacturing Practice.

The US GMP refers to the requirements set by the FDA to ensure the quality, safety, and efficacy of medical devices, pharmaceuticals, biologics, food, and cosmetics manufactured in the United States.

The FDA outlines specific QMS requirements for medical device manufacturers under 21 CFR Part 820. The 21 CFR Part 820 regulation sets forth the Current Good Manufacturing Practice (CGMP) requirements for medical devices.

EU GMP for Medical Device Manufacturing

EU GMP stands for European Union Good Manufacturing Practice. The EU GMP guideline helps ensure the quality and safety of medicinal products, medical devices, food, and cosmetics.

In the European Union, medical device manufacturers are required to comply with EU GMP under the MDR. These GMP requirements ensure the production of medical devices with high and uniform safety and quality.

Compliance with the MDR and obtaining CE Marking are essential for manufacturers to market and sell medical devices across the 30 countries within the European Economic Area (EEA).

WHO GMP for Medical Device Manufacturing

The WHO GMP are the GMP requirements set forth by the World Health Organization (WHO). The WHO GMP helps ensure products are consistently produced and controlled in compliance with quality standards appropriate to their intended use.

WHO GMP outlines requirements that are broadly applicable to various medical products, including medical devices and pharmaceuticals. The WHO GMP specifies requirements for everything that directly or indirectly affects the product’s safety and quality, including personnel, materials, premises, and methods.

Other National GMPs for Medical Device Manufacturing

Various countries have their own GMP requirements. National GMP often aligns with international standards but may have additional specific regulations and guidelines.

Manufacturers exporting to different countries must comply with the respective GMPs.

QMS Requirements for Pharmaceutical Manufacturing

Relevant QMS requirements that apply to pharmaceutical manufacturing are presented below.

• ICH Q10
• PIC/S GMP
• Good Manufacturing Practice (GMP), including EU GMP, US GMP, WHO GMP, and others.

ICH Q10

ICH Q10 is a guideline by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The ICH Q10 guideline describes a model for an effective quality management system for the pharmaceutical industry, referred to as the Pharmaceutical Quality System (PQS).

The ICH Q10 provides a comprehensive framework for establishing and maintaining the PQS throughout the product lifecycle. ICH Q10 aims to enhance the quality and availability of medicines worldwide in the interest of public health.

Implementing the ICH Q10 pharmaceutical quality system across the product lifecycle encourages innovation and continuous improvement and strengthens the link between pharmaceutical development and manufacturing processes.

PIC/S GMP

The PIC/S GMP is the GMP guideline developed by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) for medicinal products.

PIC/S GMP is designed to promote harmonized standards for the quality assurance of medicinal products in the pharmaceutical industry worldwide.

The PIC/S GMP is similar to ICH Q10 and EU GMP in various aspects of pharmaceutical manufacturing. All these requirements aim to ensure that medicinal products are consistently produced and controlled in compliance with the appropriate requirements for their intended use.

Good Manufacturing Practice (GMP) for Pharmaceutical Manufacturing

Good manufacturing practices for pharmaceutical manufacturing are the regulations, standards, and guidelines that ensure the quality, safety, and efficacy of medicinal products.

These requirements ensure the consistent production and control of pharmaceutical products to comply with quality standards appropriate for their intended use.

Pharmaceutical manufacturing GMPs are enforced by regulatory agencies such as the US FDA and the European Medicines Agency (EMA).

US GMP for Pharmaceutical Manufacturing

The US GMP for pharmaceutical manufacturing is outlined in the FDA 21 CFR Part 210 and FDA 21 CFR Part 211 regulations.

FDA 21 CFR Part 210 specifies the minimum Current Good Manufacturing Practices (CGMP) for manufacturing, processing, packing, or holding of drugs. The 21 CFR Part 210 aims to ensure that drug products are safe, have identity and strength, and meet the indicated quality and purity characteristics.

FDA 21 CFR Part 211 provides more specific CGMP requirements for the production of finished pharmaceuticals. The 21 CFR Part 211 outlines the requirements necessary to ensure the quality, purity, strength, and identity of finished drug products.

The 21 CFR Part 211 covers principles applicable to the pharmaceutical industry, including several requirements related to the following areas.

• Personnel
• Buildings and facilities
• Equipment
• Control of components
• Drug product containers and closures
• Production and process controls
• Laboratory controls
• Records and reports
• Handling of complaints
• And more.

EU GMP for Pharmaceutical Manufacturing

The EU GMP guideline outlines the rules governing medicinal products in the EudraLex Volume 4.

EU GMP provides basic requirements for the manufacture of medicinal products for human and veterinary use, in addition to several specific annexes. EU GMP serves as a comprehensive resource to help pharmaceutical manufacturers maintain uniform and high quality throughout the production process.

EudraLex Volume 4 specifies the requirements for various aspects of pharmaceutical manufacturing, including facilities, equipment, personnel, documentation, quality control, distribution, and more.

Pharmaceutical companies operating within the EU or seeking to market their products in EU member states must comply with the requirements outlined in EudraLex Volume 4.

WHO GMP for Pharmaceutical Manufacturing

The WHO GMP aims to ensure that pharmaceutical products are made consistently and controlled according to suitable quality standards for their intended use and as needed for marketing approval.

GMP focuses on reducing risks in pharmaceutical production, especially related to preventing mix-ups between different products and ensuring accurate labeling.

WHO GMP also provides a foundation for creating national guidelines for GMP for biological products.

Other National GMPs for Pharmaceutical Manufacturing

Different countries have specific GMP requirements. National GMP can follow international requirements and also include specific national rules and recommendations.

Pharmaceutical manufacturers exporting to different countries must comply with the corresponding GMP requirements.

QMS Requirements for Cosmetics Manufacturing

Relevant QMS requirements that apply to cosmetics manufacturing are ISO 22716:2007 and Regulation (EC) 1223/2009 (EU Cosmetics Regulation).

ISO 22716:2007

ISO 22716:2007 standard outlines the requirements for the manufacturing processes of cosmetics. ISO 22716:2007 helps ensure cosmetic production, control, storage, and shipment.

ISO22716:2007 establishes a framework for implementing GMP guidelines to define the activities that enable companies to obtain a product that meets defined characteristics.

Regulation (EC) 1223/2009 (EU Cosmetics Regulation)

The Regulation (EC) No 1223/2009, also known as the EU Cosmetics Regulation, establishes the requirements within the European Union governing the safety, production, and labeling of cosmetic items.

The EU cosmetics regulation specifies that products must undergo rigorous testing to ensure their safety for human use under expected conditions. Companies must ensure their cosmetics comply with the EU cosmetics regulation requirements before they can be sold in the EEA market.

QMS Requirements for Food and Beverage Manufacturing

Relevant QMS requirements that apply to food and beverage manufacturing are the Global Food Safety Initiative (GFSI) and ISO 22000:2018.

The Global Food Safety Initiative (GFSI)

The Global Food Safety Initiative (GFSI) is a collaboration between various stakeholders in the food industry, including retailers, manufacturers, food service companies, and others. The GFSI helps ensure food safety standards for businesses and provides people with access to safe food.

The GFSI operates as a benchmarking organization that sets criteria for food safety management systems, which are recognized globally. GFSI approves several food safety standards covering farming, packaging, storage, and distribution.

GFSI outlines several principles and requirements related to food safety across the supply chain. GFSI includes requirements for personal hygiene and operational practices similar to GMPs. Hazard analysis and critical control points (HACCP) principles are also included in GFSI requirements, which help identify and control food safety skills.

GFSI encourages continuous improvement, improves food safety and customer loyalty, and supports regulatory compliance.

ISO 22000:2018

ISO 22000:2018 is an international standard that specifies requirements for food safety management. ISO 22000:2018 standard aims to support companies involved in the food chain to plan, implement, operate, maintain, and update a Food Safety Management System (FSMS).

ISO 22000:2018 outlines elements that must be included in an effective FSMS, for example:

• Interactive communication across the company.
• Documentation to be included in the management system.
• HACCP principles that help identify, prevent, and remove food safety hazards.

QMS Requirements for Automotive Manufacturing

The relevant QMS requirement applicable to automotive manufacturing is IATF 16949:2016.

IATF 16949:2016

IATF 16949:2016 is an international standard that outlines the QMS requirements for the design, development, production, installation, and service of automotive-related products.

IATF 16949:2016 standard focuses on continuous improvement, defect prevention, and reduction of variation and waste in the supply chain. The IATF 16949:2016 shares similarities with ISO 9001:2015 in terms of QMS core principles and structure.

IATF 16949 standard includes additional automotive-specific requirements tailored to the unique needs and challenges of the automotive industry, such as control of repaired products, automotive product-related software, and engineering specifications.

QMS Requirements for Aviation, Space, and Defense Manufacturing

Relevant QMS requirements that apply to aviation, space, and defense manufacturing are the AS9100, AS9110, and AS9120.

AS9100

AS9100 is an internationally recognized quality management standard for the aerospace industry. AS9100 specifies requirements for establishing, implementing, and maintaining a quality management system to ensure the consistency and quality of aerospace products and services.

AS9100 applies to all aerospace organizations, from design and manufacturing to maintenance and stockist distributors.

AS9100 incorporates all the ISO 9001:2015 requirements and supplements them with additional criteria tailored to the aviation, space, and defense sectors, such as counterfeit parts prevention and reporting.

AS9110 and AS9120

AS9110 and AS9120 are quality management system standards for aerospace maintenance companies and aerospace distributors, respectively.

These standards outline specific requirements for companies involved in maintenance, repair, and overhaul activities and aerospace parts distribution.

What are the Primary QMS Processes in Manufacturing?

The primary quality management system processes in manufacturing are listed below. This article focuses on manufacturing, so the design and development process is not included.

• Document Control
• Change Control
• Training Management
• Deviation and Nonconformance Management
• CAPA Management
• Complaint Management
• Audit Management
• Supplier Management
• Risk Management
• Equipment Management
• Product Management

Examples of how SimplerQMS software can streamline each QMS process will be provided.

Document Control

Document control encompasses creating, reviewing, approving, storing, distributing, and revising documents within the quality system.

The document control process maintains the integrity of manufacturing operations and helps achieve compliance with regulatory and customer requirements. Effective document control prevents errors and inconsistencies in product quality by ensuring all personnel access up-to-date and accurate documents.

An eQMS with robust document control capabilities, like SimplerQMS, streamlines the document control process. The eQMS facilitates control of document versions, easy access to currently in-use documents, and the secure storage and retrieval of in-use and obsolete documents.

Automated notifications related to document release, review, and approval activities reduce time and effort in document creation and approval cycles. Additionally, eQMS solutions provide capabilities for electronic signatures, time-stamped audit trails, and controlled printing.

Change Control

Change control is the process of managing all changes within manufacturing companies related to processes, procedures, products, documents, templates, and others. Change control involves evaluating, approving, implementing, and monitoring changes to ensure they are controlled and documented.

Change control prevents disruptions and defects that arise from uncontrolled changes, ensuring that any modification is thoroughly assessed.

Electronic QMS, such as SimplerQMS, provides capabilities to streamline the change control process. The eQMS automates the workflow of change requests, from initiation through review, approval, implementation, and effectiveness assessment.

SimplerQMS change control module facilitates monitoring change status and related documentation updates with automatic notifications and task reminders. The eQMS software enables real-time collaboration across departments, ensuring all employees participate in the change management process.

Training Management

Training management is the process of managing employee training and development programs, from initial planning and resource coordination to execution and evaluation. A well-established training management process ensures that the workforce possesses the necessary skills and knowledge to perform their tasks.

Training management ensures that employees are aware of their roles and responsibilities within the company. Effective training programs contribute to risk mitigation and foster a culture of continuous improvement by empowering employees with the knowledge necessary to manage risks.

The eQMS streamlines training management, automating tasks such as assigning training activities, sending email notifications, conducting training effectiveness assessments, and tracking training progress.

The training management capabilities in SimplerQMS can enhance scheduling, tracking, and follow-up of training gaps and missed deadlines, eliminating delays for employees to acquire applicable knowledge.

Deviation and Nonconformance Management

Deviation and nonconformance are events within a process or procedure in which the result does not comply with the established requirements.

Inefficient management of deviations and nonconformance can result in non-compliance with internal policies, procedures, or regulatory and customer requirements. A well-structured deviation and nonconformance management process helps companies identify the root cause of issues and prevent potential problems in product or service quality.

Quality management software streamlines the management of deviations and nonconformance management, facilitating timely investigation and resolution. With eQMS solutions, like SimplerQMS, companies efficiently manage the entire lifecycle of a deviation or nonconformance, from initial detection through to closure and effectiveness assessment.

The features an eQMS provides in the context of nonconformance and deviation management include automated workflows for recording, reviewing, and closing deviations and nonconformances. QMS software integrates with other connected QMS processes, such as CAPA (Corrective and Preventive Actions), to ensure comprehensive issue resolution.

CAPA Management

CAPA (Corrective and Preventive Action) management is a process aimed at preventing issues, such as deviations and nonconformances, from occurring. CAPA process identifies and addresses the root cause of issues by systematically investigating discrepancies in procedures and products.

Companies implement corrective actions to address current issues and preventive actions to prevent the recurrence of similar issues.

The CAPA process typically comprises several key steps: identification, evaluation, investigation, analysis, action plan, implementation, and follow-up.

Implementing QMS software with CAPA management capabilities streamlines the entire CAPA process, from identifying issues to resolving and closing them. The eQMS automates workflows, improves accountability, and helps ensure CAPA-related tasks are completed on time.

With an eQMS, like SimplerQMS, companies can efficiently manage all steps of the CAPA process, including root cause analysis, action planning, action implementation, effectiveness checks, and closures.

Complaint Management

A complaint is an expression of dissatisfaction made by a customer to a company regarding its product or service. Complaint management involves the systematic handling, investigation, and resolution of customer complaints.

Customer complaint management is essential for companies due to the impact on product quality, safety, and customer trust. Complaint management is a diagnostic tool to identify and rectify underlying issues, with each complaint acting as a symptom.

Implementing eQMS with complaint management capabilities facilitates the efficient recording, tracking, and resolution of complaints. With the SimplerQMS complaint management module, companies can automate task assignments, track complaint progress, and maintain a centralized repository of complaint records and related documentation.

The software enables easy linkage of complaints to specific products and lot numbers and integration with other modules, such as CAPA, facilitating comprehensive issue resolution and continuous improvement.

Audit Management

Audit management is a systematic process that manages all activities related to auditing, from planning and scheduling to conducting and documenting audit findings. Audits assess the effectiveness of the QMS and compliance with regulatory and customer requirements and help identify areas for improvement.

With regular audits, companies verify compliance with internal and external requirements, identifying gaps in quality management practices. Audit findings can lead to corrective and preventive actions, mitigating potential risks.

An eQMS facilitates the scheduling and planning of audits (regulatory, supplier, internal), the assignment of auditors, and the tracking of audit findings and recommendations.

SimplerQMS audit management module streamlines the creation of audit checklists, allows the compilation of audit findings electronically, and manages follow-up activities more efficiently. The eQMS ensures that audit records are securely stored and easily accessible for review and analysis.

Supplier Management

Supplier management involves selecting, evaluating, and monitoring suppliers to ensure they comply with relevant regulatory and customer requirements.

Effective supplier management ensures that materials and components sourced from suppliers meet quality specifications, reducing the risk of product failures, recalls, and non-compliance issues. The supplier management process also ensures strong supplier relationships and supply chain continuity and supports the company’s overall quality objectives.

eQMS software streamlines supplier qualification processes and the handling of supplier-related documentation, including contracts, quality agreements, and required certificates.

Through SimplerQMS, companies can consolidate supplier data, simplifying the process of evaluations and audits. The supplier management module automatically notifies about re-evaluations or necessary follow-up actions according to a set schedule, helping ensure compliance and quality assurance.

Risk Management

Risk management is a systematic process of identifying, assessing, prioritizing, and mitigating risks that can affect product quality and safety. Risk management involves analyzing issues, evaluating potential impacts, and developing strategies to manage or minimize adverse effects.

The risk management process typically comprises five essential steps.

1. Risk Identification
2. Risk Assessment
3. Risk Control
4. Risk Review
5. Risk Communication

Risk management is essential in highly regulated industries to ensure products and services maintain compliance with regulatory and customer requirements. By identifying and assessing quality risks early on, measures can be taken to prevent or mitigate risks.

eQMS with risk management capabilities facilitates the systematic documentation, analysis, and reporting of risks.

SimplerQMS risk management module provides automated workflows to ensure that risk-related tasks are promptly addressed. Notification and reminders ensure decision-makers are informed of significant risk changes. The eQMS offers the capability to link risk-related documents to related processes, documents, and CAPAs, providing a comprehensive view of risk management activities.

Equipment Management

Equipment management is the process of managing all aspects of a manufacturing facility’s equipment. Equipment management ensures that equipment is calibrated, maintained, and operated in a manner that supports product quality, safety, and compliance.

Equipment management includes scheduling regular maintenance, calibration, validation, and ensuring that equipment operates within specified parameters.

Properly managed equipment reduces the risk of production downtime, product quality issues, and non-compliance with regulatory and customer requirements.

eQMS allows the scheduling of maintenance and calibration activities, tracks the history of equipment performance, and manages documentation related to equipment validation and operation procedures. Equipment can be directly linked to specific standard operating procedures (SOPs), work instructions, and maintenance tasks.

SimplerQMS offers notifications for upcoming maintenance or calibration tasks, ensuring these critical activities are not overlooked. The equipment management module also allows for the centralization of equipment records, making it easier to access and review historical data, maintenance logs, and compliance documents.

Product Management

Product management is the systematic process of managing a product’s lifecycle, from design to manufacturing. Product management helps ensure products are safe and comply with customer and regulatory requirements.

Product management involves tasks such as product design, development, production scheduling, manufacturing, and quality control.

An eQMS with product management capabilities streamlines product management processes by centralizing product data, enabling effective collaboration across departments, and tracking product manufacturing stages.

SimplerQMS offers product management capabilities by streamlining the organization of product-related information. The QMS software allows the relation of documents to products, product lots, equipment, suppliers, customers, documents, and more. Companies can use product release notes to consolidate documents related to the manufacturing process and products through hyperlinks.

What is the Role of QMS Software for Manufacturing Companies?

The eQMS software for manufacturing companies streamlines and improves quality management processes.

eQMS software centralizes and automates the management of quality processes, supports compliance with regulatory requirements, improves efficiency, and helps maintain product safety and quality.

QMS software allows the management of QMS processes, including document control, change management, CAPA management, training management, audit management, supplier management, risk management, and equipment management, among others.

A key capability of QMS software is the integration with other software applications, such as ERP (Enterprise Resource Planning), MES (Manufacturing Execution System), PLM (Product Lifecycle Management), SCM (Supply Chain Management) systems, and more.

SimplerQMS is a ready-to-use eQMS tailored specifically for Life Sciences companies, including pharmaceutical, medical devices, biotechnology, laboratories, CROs, and CMOs. SimplerQMS streamlines all QMS processes with automated workflows and interlinked documents, ensuring seamless and efficient workflow.

SimplerQMS’ comprehensive support of QMS processes helps companies to comply with various QMS requirements in the Life Sciences industry, including ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 820, GMP, EU MDR, ICH Q10, among others.

SimplerQMS is fully validated according to ISPE GAMP5. The system is kept in a validated state, with continuous updates whenever new versions or changes are introduced, ensuring compliance and readiness for audits and inspections.

Experience how SimplerQMS streamlines QMS processes and supports your Life Science company’s needs. Book a demo and speak with our Quality Solution Consultants experts.

The post Quality Management System (QMS) for Manufacturing appeared first on SimplerQMS.

Companies use eQMS primarily to streamline processes, ensure regulatory compliance, and improve overall quality management across their operations.

The eQMS software supports quality teams in managing and tracking quality management-related processes, such as document control, change management, training management, supplier management, and many others, in a centralized and efficient manner.

Companies utilizing eQMS benefit from improved customer and regulatory compliance, streamlined processes, and increased efficiency.

When choosing an eQMS, companies should first assess the specific requirements applicable to them, thoroughly research and compare QMS software vendors, participating in demo meetings. Companies must ensure that the QMS software aligns with the company’s needs and objectives.

This article discusses what an eQMS stands for, what is included in an eQMS, why companies adopt eQMS, its functions, and its benefits. Additionally, the article briefly explains how to choose the right eQMS solution, offering key considerations, and provides examples of the best QMS software for Life Sciences.

SimplerQMS offers a fully GAMP 5-validated eQMS software designed specifically for Life Science companies. Book a demo to see how our solution streamlines quality management processes and helps ensure compliance.

Explore the specific topics covered in this article:

• What is an eQMS?
• Why Do Companies Use an eQMS System?
• What Does eQMS Software Do?
• What Are The Benefits of eQMS Software?
• What Makes a Good eQMS Software?
• How to Choose an eQMS Software?
• The 9 Best QMS Software Solutions for Life Sciences

What is an eQMS?

An electronic Quality Management System (eQMS) is a digital platform designed to centralize, automate, and streamline quality-related processes within a company. The eQMS encompasses features such as document control, change management, training management, Corrective and Preventive Actions (CAPA), risk management, audits management, and others.

An eQMS is the digital format of a quality management system, offering a modern approach to managing quality management processes. Other formats of QMS include traditional paper-based QMS relying on physical documentation and hybrid systems that combine digital and paper-based formats of quality management.

Companies facing challenges with paper-based and hybrid QMS, like lost documents, outdated records, and inefficient processes, can benefit from implementing an eQMS. An eQMS aids companies in overcoming paper-based and hybrid system challenges by automating quality management processes and simplifying the tracking and management of data, documents, and workflows.

Typically, an eQMS is deployed as a cloud-based quality management system. The cloud-based nature of eQMS makes it accessible to authorized users anywhere, at any time, and on authorized devices with an internet connection.

While cloud-based eQMS are popular solutions, an on-premise option also exists, allowing companies to host the system’s infrastructure in a way that best fits their needs and preferences.

Electronic QMS supports companies in achieving and maintaining regulatory compliance. It enables companies to monitor compliance with industry regulations, standards, and guidelines and proactively identify and address issues.

What is the Difference Between Electronic QMS (eQMS) and Enterprise QMS (EQMS)?

While eQMS stands for Electronic Quality Management System, the term can occasionally be associated with Enterprise Quality Management System (EQMS).

Electronic Quality Management System (eQMS) refers to a digital platform designed to automate and streamline quality management processes.              

Enterprise Quality Management System (EQMS) is the quality management software large enterprise-size companies utilize to manage their quality management processes. Many larger companies and enterprises have adopted eQMS as their quality system due to the difficulties of maintaining a manual QMS at scale.

Enterprises can utilize one or more eQMS software solutions depending on their needs. Enterprises utilize specific functionalities within the eQMS, such as site functions, which enable organizations to restrict access to specific documents based on user roles assigned to individual sites.

SimplerQMS provides broad QMS process support and scalability, being an Enterprise Quality Management System provider. SimplerQMS eQMS software offers the ability to manage different sites. Each site can access documents specific to them while following the same predefined workflows across the organization.

Why Do Companies Use an eQMS System?

Companies use an eQMS system to streamline quality management processes, reduce costs, increase efficiency, and help ensure regulatory compliance.

Implementing an eQMS is beneficial for companies that need to comply with comprehensive customer and regulatory requirements. For instance, eQMS benefits companies in the Life Science industry, such as pharmaceutical, biotechnology, and medical devices. The eQMS provides support for QMS processes to ensure continuous improvement and compliance with requirements.

Life Science companies must comply with regulations, standards, and guidelines that outline the requirements for the Quality Management System (QMS).

What Does eQMS Software Do?

The electronic QMS software automates and streamlines the handling of documents, policies, procedures, and processes essential for ensuring product safety and effectiveness. The eQMS software provides a centralized repository for all documents and data, making it easy to manage quality processes and workflows.

Electronic QMS streamlines quality processes and facilitates compliance with requirements by offering features like document control, change management, training management, audit management, supplier management, and many more. The eQMS enhances operational efficiency, improves efficiency, increases collaboration among team members, and helps ensure compliance.

A suitable eQMS should seamlessly integrate with a company’s existing operations, ensuring a harmonious alignment with established quality management processes.

An effective eQMS should optimize quality management processes by enabling companies to:

• Efficiently create, modify, review, approve, and retire documents.
• Securely approve documents using electronic signatures.
• Manage document versions and control access based on user roles and permissions.
• Monitor and handle quality events like nonconformances, customer complaints, audit findings, and CAPAs.
• Simplify and guide through various quality management processes, including employee training management, change control, design control, risk management, equipment calibration, supplier management, and more.
• Generate reports and analyze quality data to recognize trends and areas for ongoing improvement.
• Strategically plan, schedule, execute, and document quality audits.
• Assist in maintaining compliance with applicable requirements.

What Are The Benefits of eQMS Software?

The benefits of implementing QMS software include the following.

• Improved Compliance: eQMS software helps ensure that companies comply with customer and regulatory requirements. The software’s predefined workflows guide users through the correct process steps. All actions are automatically documented in a time-stamped audit trail.
• Improved Process Efficiency: By streamlining workflows and automating repetitive tasks, eQMS software improves process efficiency, reducing the need for manual work.
• Improved Product Quality: eQMS software helps enforce consistent execution of quality procedures throughout predefined workflows. Electronic QMS helps achieve higher and more uniform product quality and fewer deviations and nonconformances.
• Enhanced Communication: The eQMS software fosters collaboration and communication among team members. The software provides a centralized platform for sharing information, feedback, and updates.
• Cost Reduction: By reducing quality issues and streamlining processes, eQMS platform helps lower operational costs. eQMS also enables companies to optimize resource allocation with data-driven decision-making.
• Audit Readiness: eQMS software maintains accurate and up-to-date histories of quality-related activities, making companies well-prepared for audits and inspections. The eQMS facilitates access to documentation, document retrieval, evidence of compliance, and traceability, ensuring smooth audit processes.
• Data-Driven Decision-Making: The eQMS software provides quality data, and KPI reports that allow companies to identify quality performance, trends, and areas for improvement. eQMS software enables companies to make informed decisions based on quality data, driving continuous improvement and strategic planning.

What Makes a Good eQMS Software?

Below are the key factors contributing to good eQMS software.

• QMS Process Support: The software offers comprehensive support for all quality management processes.
• Computer System Validation (CSV): Fully validated eQMS software ensures compliance with requirements regarding computer system validation.
• Regulatory Compliance: Good QMS software supports compliance with industry-specific requirements.
• Flexible Implementation Process: A flexible implementation process enables companies to tailor the software implementation to their specific needs.

Additional details on each factor contributing to a good eQMS software are presented below.

QMS Process Support

The QMS software provides comprehensive support for all quality management processes.

A good QMS software supports processes such as:

• Document Control
• Change Control
• Training Management
• Supplier Management
• Design Control
• Risk Management
• Audit Management
• Nonconformance and Deviation Management
• CAPA Management
• And more.

Computer System Validation (CSV)

Fully validated eQMS software ensures compliance with regulatory requirements, safeguards data integrity, and helps maintain product quality and safety.

Computer System Validation (CSV) is the process used to ensure a computerized system meets its intended use consistently. Validation of quality management system software is a requirement when the software is used to manage regulated processes.

The validation of QMS software involves three key stages: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). These protocols ensure that the software is correctly installed, functions as intended, and performs effectively in real-world scenarios.

SimplerQMS offers a fully validated eQMS solution in accordance with ISPE GAMP 5. The software remains in a validated state at all times, with SimplerQMS managing all validation and revalidation tasks.

Regulatory Compliance

QMS software supports compliance with regulations, guidelines, and standards that outline QMS requirements applicable to companies operating in specific industries, such as the Life Science industries. Good QMS software facilitates quality processes to ensure adherence to regulatory requirements.

For example, for pharmaceutical companies, specific requirements include compliance with guidelines for pharmaceutical quality systems like ICH Q10 and Good Manufacturing Practices (GMP) regulations such as FDA 21 CFR Part 211.

In the medical device industry, requirements encompass standards for quality management systems, such as ISO 13485:2016, current Good Manufacturing Practices (cGMP) like FDA 21 CFR Part 820, as European regulations such as Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Additionally, common QMS requirements can apply to several industries, including the general quality management systems standard ISO 9001:2015. Other requirements QMS software solutions often comply with include the cybersecurity standard ISO 27001:2022 and the regulation for electronic signatures and records, such as FDA 21 CFR Part 11, as well as requirements for using computerized systems EU Annex 11.

Compliance With FDA 21 CFR Part 11

The QMS software that is compliant with the 21 CFR Part 11 regulation follows a comprehensive framework for managing electronic records and signatures in a secure and compliant system.

The United States Food and Drug Administration (FDA) 21 CFR Part 11 is a regulation that aims to ensure electronic records and electronic signatures’ integrity, reliability, and authenticity.

SimplerQMS offers 21 CFR Part 11-compliant eQMS software specifically designed for Life Science companies. The eQMS software includes controls for electronic signatures and records, including management of passwords and identification codes, automatic linking of signatures to records, and comprehensive audit trails, among many other functionalities.

Compliance With EU Annex 11

By complying with EU Annex 11, an eQMS demonstrates its reliability, security, and integrity in managing electronic records and signatures. The eQMS effectively safeguards data, maintains audit trails, and upholds the authenticity of electronic documentation.

The EU Annex 11 is the European Union guideline establishing the requirements for computerized systems within GMP-regulated activities. EU Annex 11 includes requirements for electronic records and electronic signatures.

SimplerQMS provides eQMS software designed for Life Science companies and complies with EU Annex 11. The eQMS complies with computerized system requirements, including system validation, generation of audit trails, appropriate personnel training, secure data storage, records retrieval, and security measures.

Flexible Implementation Process

A good eQMS software is characterized by a flexible implementation process, which empowers companies to tailor the software implementation according to their specific needs and timelines.

A flexible implementation process allows companies to customize the implementation phases by prioritizing the implementation of certain QMS modules and accommodating upcoming audits or inspection deadlines.

For example, some companies need to fast-track implementation for upcoming audits, while others prefer a longer implementation period.

Companies focused on manufacturing may prioritize implementing Equipment or Suppliers Management modules, while companies dealing with recorded issues prioritize implementing the CAPA (Corrective and Preventive Actions) Management module.

SimplerQMS’s Customer Success team collaborates with customers in kick-off meetings to outline a personalized plan for QMS software implementation. SimplerQMS offers a phased implementation process. Each phase focuses on implementing and providing training for specific QMS modules, which can be customized to the needs of each customer.

How to Choose an eQMS Software?

Choosing an eQMS software involves several steps to ensure that the selected solution aligns with the company’s needs and objectives.

The steps companies can follow to choose an eQMS software are mentioned below.

1. Assess Your Requirements: Identify all relevant regulations, standards, and guidelines the company needs to comply with. Outline the functionalities the QMS software needs to have to comply with the applicable requirements.
2. Research and Compare QMS Software Vendors: Gather information about vendors and their solutions through Requests for Information (RFI), Requests for Quotation (RFQ), and Requests for Proposal (RFP). Compare the chosen QMS software and vendor features side-by-side.
3. Select Relevant QMS Software Vendors:  Based on information from RFI, RFQ, and RFP, choose vendors that best align with the company’s needs. Consider vendor reputation and customer reviews.
4. Get Demos and Have Meetings: Request demos from shortlisted vendors to see how the software operates and assess its suitability. Schedule follow-up meetings to explore specific QMS modules and clarify doubts.
5. Consider Getting a Trial:  Request a trial period to evaluate the software’s functionality, usability, and compatibility with existing workflows.
6. Shortlist QMS Software Vendors:  Narrow down the QMS software options based on the information gathered from demos, meetings, and trials.
7. Get Demonstration of Specific Use Cases:  Request demonstrations tailored to address specific use cases and scenarios, ensuring the software addresses daily operations.
8. Negotiate With Shortlisted QMS Providers: Negotiate with shortlisted vendors for favorable terms regarding pricing, contract terms, implementation timelines, and any additional needs.
9. Make Final Decision:  Carefully consider all information, including demos, trials, and negotiations, to choose the QMS software that best aligns with the company’s needs and offers the most comprehensive solution.

Simplify your decision-making process by downloading our complimentary QMS Software Comparison Template.

Utilize the template to perform a comprehensive side-by-side comparison of different QMS software solutions, assessing vendor features, functionalities, and pricing structures tailored to your specific requirements.

What Are the Key Considerations When Choosing an eQMS Software?

Below are some considerations for selecting the right QMS software.

Be aware that choosing QMS software involves a comprehensive series of steps and considerations to ensure the final decision aligns with the company’s needs and objectives.

• Quality Management System Needs: Clearly outline the company’s quality management system needs. Identify specific quality processes, compliance requirements, and features an eQMS must address.
• Training and Support: Consider the training options and support provided by an eQMS vendor. Adequate training ensures that users can maximize the system’s capabilities, while reliable support is essential for addressing any issues.
• Validation and Certification: Look for eQMS software that has undergone validation processes and follows the Good Automated Manufacturing Practice (GAMP), such as ISPE GAMP 5.
• Additional Features: Evaluate the supporting technology offered by the QMS. Supporting technology may include real-time data dashboards, mobile accessibility, a document editing interface, integration possibilities, and reporting solutions.
• Cloud-Based Deployment: Consider opting for a cloud-based eQMS. Cloud solutions offer accessibility, flexibility, and often include regular updates without requiring extensive on-premise infrastructure.

When Is the Right Time to Consider an eQMS?

Life Science companies often consider implementing an eQMS once they have established or are actively developing their quality management system and associated documentation.

Determining the precise moment to implement a QMS software is complex.

The five main reasons to consider an eQMS are listed below.

• Improving communication across departments
• Automating QMS processes
• Improving compliance efforts
• Gaining better visibility into quality data
• Seeking scalability

While finding the ideal time is challenging, companies gain greater benefits by implementing an eQMS sooner rather than later. Early adoption of QMS software allows companies to build a robust foundation for ensuring quality and compliance.

How Much Time Does It Take to Implement QMS Software?

The comprehensive QMS software solution is typically implemented within a timeframe of 5 to 6 weeks.

The duration of QMS software implementation may vary based on factors such as the number of documents requiring creation or migration, as well as the availability of time resources within the company.

For example, SimplerQMS software implementation follows a structured phase approach that focuses on deploying distinct QMS modules. The SimplerQMS implementation allows for customizable QMS module sequences based on individual requirements, with all implementation activities and associated training provided at no extra charge.

How Much Does an eQMS Cost?

The cost of the software may vary depending on factors such as the number of QMS modules, licenses, and add-ons like implementation and training, among others.

For instance, QMS software prices usually start at $13,000 for a company with 5 to 10 employees. The price range for QMS software can vary from $25,000 to $100,000 for companies with 50 to 200 employees.

SimplerQMS provides an all-inclusive solution that includes all QMS modules, system implementation, user training, ongoing support, validation, and cloud hosting within the yearly license cost.

The pricing structure of SimplerQMS is determined by the number of licenses acquired. The license price covers all features and services, eliminating the need for additional costs.

Visit our pricing page for detailed information regarding costs and the features and services provided.

The 9 Best QMS Software Solutions for Life Sciences

The 9 best QMS software solutions for Life Sciences are listed below. The best QMS software solution for the Life Sciences list results from the expertise of our quality specialists, feedback from customers and partners, and extensive research.

1. SimplerQMS

SimplerQMS is a cloud-based quality management system (QMS) software specifically designed for companies in the Life Sciences industry. SimplerQMS offers comprehensive support for all QMS processes, including document control, training management, change management, non-conformance and deviation management, CAPA management, design control, audit management, equipment management, and more.

SimplerQMS software seamlessly integrates with the Microsoft suite, allowing for easy document editing and collaboration using familiar tools such as Word, Excel, and PowerPoint.

The software is fully validated according to GAMP 5. SimplerQMS helps companies comply with various regulatory requirements related to Life Sciences, such as GxP, ISO 13485:2016, 21 CFR Part 11, EU Annex 11, and others.

SimplerQMS is available as an all-inclusive annual subscription with pricing based on the number of user licenses. The subscription includes all QMS modules, system implementation, training, validation, hosting, and support. Users appreciate the software’s ease of use and good value for the price, and customer support is often praised for its expertise and responsiveness.

2. Qualio

Qualio offers a cloud-based quality management platform specifically designed for growing Life Science companies in medical devices, pharmaceuticals, and biotechnology.

The software provides core QMS functionalities like document management, risk management, and training. Qualio helps ensure compliance with requirements such as FDA 21 CFR Part 11, ICH Q10, GxP, ISO 13485:2016, and more. While pre-validated according to GAMP 5, some additional customer-side validation is required.

Qualio is known for its ease of use, efficient implementation process, and helpful customer support. It integrates with various popular apps but lacks integration with Microsoft Office. Pricing is tiered based on features and user licenses.

3. MasterControl

MasterControl offers QMS solution catering to various industries, including pharmaceuticals, medical devices, and food and beverage. Primarily targeted at large enterprises, MasterControl manages core quality processes like document control, training, and nonconformance management, among others.

MasterControl software is FDA 21 CFR Part 11 compliant and supports various requirements, such as FDA regulations, ISO requirements, CLIA, EU MDR, and more.  The software automates GAMP 5 processes and offers a patented Validation Excellence Tool (VxT) for user-friendly software validation. 

MasterControl is known for its robust document management features and easy integration with other software applications, such as Enterprise Resource Planning (ERP), Customer Relationship Management (CRM), Manufacturing Execution Systems (MES), and more. Pricing is tiered based on features, users, and additional services.

4. TrackWise

TrackWise offers both on-premise (TrackWise) and cloud-based (TrackWise Digital) QMS solutions with AI-powered features for proactive quality management.

The software caters to various industries, including pharmaceuticals, medical devices, and food and beverage. TrackWise centralizes all QMS processes for improved efficiency, compliance, and risk reduction. 

TrackWise supports Life Science requirements, such as FDA 21 CFR Part 11, 211, and 820, EU Annex 11, MDR, ICH Q9, Q10, and Q11, GxP, and ISO standards. The software provides a computer system validation package for each software release.

Pricing is customized based on user needs and requires contacting sales for a quote. Users appreciate the high level of configurability and integration with other business systems like Salesforce.

5. Ideagen Quality Management

Ideagen Quality Management is a modular eQMS solution catering to diverse industries like life sciences, manufacturing, and healthcare.

Ideagen offers a comprehensive suite of QMS modules like document control, audit management, CAPA, and others, all integrated and streamlined with automated workflows. The software uses familiar tools like Microsoft Office for document editing.

Ideagen, in collaboration with CompliancePath, provides end-to-end validation services. While basic validation is included, full validation requires additional investment.

User praise focuses on the system’s document control, CAPA management features, and exceptional customer support. Pricing remains undisclosed but can be purchased as a perpetual license or subscription.

6. Greenlight Guru

Greenlight Guru is a cloud-based QMS platform designed specifically for the MedTech industry. Greenlight Guru offers comprehensive QMS modules, including document management, training, and risk management, among others, alongside specialized features for design control and clinical trials.

Greenlight Guru stands out for its ease of use and risk-based computer system validation package, aligning with FDA regulations and best practices. Users benefit from in-app document editing and a native traceability matrix generation tool.

The software offers tiered subscription plans with dedicated support and on-demand training resources. Medical device industry experts guide implementation, and it can be completed within 2-8 weeks.

Greenlight Guru is praised for its intuitive interface and well-structured workflows, particularly for design control and risk management, making it a strong choice for MedTech companies.

7. Dot Compliance

Dot Compliance offers a pre-configured, cloud-based QMS built on the Salesforce platform. Dot Compliance software provides features like interconnected QMS modules, facilitating management across various quality processes. The software offers an AI assistant for data insights.

Dot Compliance allows for document management with Microsoft Office integration, keeping document editing in familiar applications.

The software supports compliance with FDA regulations, GMP, EU MDR, ISO 9001:2015, 13485:2016, 14791:2019, 27001:2022, and more. Dot Compliance helps ensure GAMP 5 compliance with a fully executed validation package.

Dot Compliance offers tiered pricing with various features and modules depending on the chosen plan, making it a scalable solution for growing Life Science companies.

8. QT9

QT9 offers a cloud-based quality management system that attends companies of all sizes across various industries, including Life Sciences, manufacturing, and food and beverage.

The software offers over 23 built-in QMS modules, including document control, risk management, and training. QT9 supports compliance with various requirements like FDA regulations and ISO standards. The software provides free validation reports (IQ, OQ, PQ) with every update.

QT9 is known for its scalability with a modular pricing structure, unlimited training options, and a free 30-day trial. Customers also appreciate its user-friendly interface and strong integration with their existing technology, especially with its own ERP system.

9. Scilife

Scilife offers a cloud-based quality management platform designed to streamline quality management processes and empower Life Science companies. Scilife provides core QMS modules such as document management, training, CAPA, and others. The software seamlessly integrates Microsoft Office for document editing.

Scilife is validated according to GAMP 5 on the Amazon Web Services (AWS) platform, taking care of most user validation tasks. Scalable pricing with a free plan and tiered options allows companies of all sizes to benefit. Users praise Scilife’s affordability, ease of use, and excellent customer support.

Learn More About SimplerQMS Today

Now that you know all about what eQMS is and some of the best Life Science eQMS software on the market, it is time to evaluate which one is right for your Life Science company.

Let’s take the next step in streamlining your quality management journey today.

You can book a demo with one of our Quality Solution Consultants to discover how SimplerQMS can benefit your company.

The post What is an eQMS? (Plus the 9 Best eQMS for Life Sciences) appeared first on SimplerQMS.

A Quality Management System (QMS) software helps ensure high and uniform quality of products and services in compliance with customer and regulatory requirements. The QMS software provides tools for managing quality-related tasks, such as document control, change management, training management, audit management, and supplier management, among others.

Choosing the right quality management software is essential for optimizing quality processes, ensuring compliance, increasing operational effectiveness, decreasing workload, and reducing costs.

Selecting QMS software requires going through a series of steps and considering various aspects, which will be explained in this article. These steps and considerations are essential for making an informed decision that aligns with the company’s needs and objectives.

SimplerQMS provides comprehensive QMS software designed to meet the unique needs of Life Science companies. Book a demo with our Quality Solution Consultants to learn more.

Table of Contents

• 1. Assess Your Requirements
• 2. Research and Compare QMS Software Vendors
• 3. Select Relevant QMS Software Vendors
• 4. Get Demos and Have Meetings
• 5. Consider Getting a Trial
• 6. Shortlist QMS Software Vendors
• 7. Get a Demonstration of Specific Use Cases
• 8. Negotiate With Shortlisted QMS Providers
• 9. Make Final Decision
• What More to Consider When Selecting QMS Software?

1. Assess Your Requirements

The first step in choosing the right QMS software is a thorough assessment of the company’s specific needs and objectives related to customer and regulatory requirements.

Companies should identify all relevant guidelines, quality standards, and regulations to which they must comply.

The requirements may include general guidelines for computerized systems effectiveness, like ISPE GAMP 5, and general QMS requirements, such as ISO 9001:2015. They may also encompass specific requirements for medical device QMS, such as ISO 13485:2016, pharmaceutical QMS, such as ICH Q10, and medical laboratory competence standards, like ISO 15189:2022, among many others.

Additionally, companies should outline functional requirements, such as the system’s capability to perform specific tasks to ensure the software fulfills all necessary criteria. For instance, the system must be able to generate time-stamped audit trails, be deployed as a cloud-based solution, integrate with other systems, and support compliant electronic signatures.

2. Research and Compare QMS Software Vendors

Companies must gather all relevant information about QMS software vendors and their solutions to make informed decisions.

What Is the Key Information to Request From a Vendor?

The key information to request from a QMS software vendor includes product features, pricing structure, implementation process, support services, and other details. Information is typically obtained through Requests for Information (RFI), Requests for Quotation (RFQ), and Requests for Proposal (RFP).

Below is a description of what RFI, RFQ, and RFP entail:

• Request for Information (RFI): An RFI is a formal document used to gather general information from vendors about products, services, features, and pricing models.
• Request for Quotation (RFQ): An RFQ is a solicitation document used to request specific pricing information from potential vendors for a defined set of product features, number of users, license types, and implementation scope. RFQ allows for cost comparisons and helps determine budget feasibility.
• Request for Proposal (RFP): An RFP is a formal document sent to shortlisted vendors to submit proposals detailing how they would meet the requirements outlined by the requesting company. RFP typically includes information on implementation plans, support services, deliverables, number of users, chosen license type, timelines, and pricing.

For an easier QMS vendor comparison, download our QMS Software Comparison Template.

The template enables the comparison of QMS software solutions and their features side by side, providing a comprehensive overview of available options.

3. Select Relevant QMS Software Vendors

Companies should identify and choose QMS software vendors whose solutions align with the company’s specific needs and requirements. These needs and requirements should be clearly defined through the processes of RFI, RFQ, and RFP.

When selecting QMS software vendors, it is important to consider vendor reputation and customer feedback and review from reputable review platforms such as G2, Gartner, TrustRadius, Capterra, Software Suggest, GetApp, and others.

Customer feedback and reviews offer insights into the real-world experiences of other users, providing valuable information on the QMS software’s reliability, usability, and customer support. Assessing the vendor’s reputation helps gauge their credibility, track record, and commitment to customer satisfaction.

For example, customers praise SimplerQMS for its intuitive interface and excellent customer support. Customers of SimplerQMS also emphasize great value for money and ease of use.

It is important to note that each QMS software vendor may have reviews that highlight its unique characteristics. These reviews can provide valuable insights for companies when selecting a vendor for further analysis.

4. Get Demos and Have Meetings

Companies should request a system demonstration from selected QMS vendors so they can view firsthand how the QMS software operates. The demonstration provides an opportunity to assess the user interface, functionality, and suitability of the QMS software for the company’s needs. Before scheduling a demonstration, some vendors may conduct initial discovery and qualification calls.

Multiple follow-up meetings may be necessary to explore specific software modules more deeply and ensure a comprehensive understanding of the QMS software’s capabilities.

In a typical demo meeting with SimplerQMS, a Quality Solution Consultant provides an overview of the software’s features and functionalities. The overview is followed by a live demonstration showcasing key aspects such as document control, change management, and training management modules. After the demonstration, the discussion typically shifts to pricing and licensing options. Follow-up meetings can be scheduled to explore specific modules in more detail based on the company’s requirements.

5. Consider Getting a Trial

Companies can consider requesting a free trial of the QMS software to evaluate its functionality, usability, and compatibility with their workflows and processes before committing.

The trial period allows users to explore the features, test various functionalities, and assess how the software complies with specific customer and regulatory requirements.

SimplerQMS offers a sandbox trial so that potential customers can experience the software firsthand before committing. The trial period allows users to explore the features and functionalities of SimplerQMS in a simulated environment.

Many SimplerQMS customers have found value in conducting a sandbox trial before making their final decision. The trial allows potential customers to thoroughly evaluate the QMS software and its capabilities in a risk-free setting.

6. Shortlist QMS Software Vendors

Companies should narrow the list of QMS software vendors to those that best meet the company’s needs and requirements. At this stage, a company choosing a QMS software may have shortlisted 3 to 5 QMS vendors based on information gathered from demos, meetings, and trials.

Companies should assess QMS vendors and software beyond the initial cost and consider the solution’s overall value to their quality management processes.

Additionally, companies can ask for references and case studies from similar companies operating in their industry. Customer references provide insights into the real-world experiences and benefits of using QMS software.

7. Get a Demonstration of Specific Use Cases

Companies often ask shortlisted QMS software vendors to provide specific demonstrations tailored to address unique use cases and scenarios relevant to the company’s daily operations.

Exploring how the QMS software addresses specific use cases allows for a more detailed assessment of the software’s capabilities and suitability.

For example, a medical device manufacturer may request a demonstration of how the QMS software manages the design control process, including design verification and validation.

Alternatively, a pharmaceutical company may request a demonstration of how the QMS software handles deviation management processes, including a direct escalation to CAPA (Corrective and Preventive Actions).

At SimplerQMS, customers often request in-depth sessions to fully understand the QMS software’s capabilities. These sessions involve a comprehensive overview of the various modules and functionalities, such as document control, change management, and training, among others. Such in-depth sessions may last 2 to 3 hours and accommodate multiple stakeholders.

8. Negotiate With Shortlisted QMS Providers

Companies should negotiate with the shortlisted QMS providers to secure favorable terms that align with the company’s budget and requirements.

To ensure a comprehensive negotiation process, it is essential to address various relevant aspects, such as the ones presented below.

• Pricing: Negotiate the pricing structure to ensure it aligns with the company’s budget and provides value for money.
• Contract Terms: Discuss and agree upon the terms of the contract, including payment schedules, termination clauses, and renewal terms.
• Implementation Timelines: Establish realistic timelines for implementing a new QMS software. Consider factors such as data migration, training, system configuration, as well as upcoming audits, or other internal projects.
• Support Services: Define the level of support services the vendor provides, including availability, response times, and escalation procedures for addressing technical issues.
• Customization Needs: Discuss the availability of additional features and customization that may not be included in the base price but are crucial for the company’s specific needs.
• Total Cost of Ownership (TCO): Calculate the TCO of the QMS software, including initial costs, ongoing maintenance, support fees, and any additional charges for customization or upgrades.
• Service Level Agreements (SLAs): Determine the SLAs that define the level of service expected from the vendor, such as uptime guarantees, response times for support queries, and resolution times for issues.
• Training and Support Options: Evaluate the vendor’s training and support options, including on-site training, online resources, and technical support staff availability.
• Vendor Roadmap: Assess the vendor’s roadmap for future upgrades and improvements to ensure the software remains relevant and aligned with the market needs.
• Legal and Compliance Issues: Address key legal and compliance issues during negotiation, such as data privacy laws, regulatory requirements, and intellectual property rights.
• Contract Review: Emphasize the importance of a detailed review of the contract by legal counsel before signing.

9. Make Final Decision

Companies should choose the QMS software vendor that best aligns with their requirements. The choice is made after considering all gathered information, including demonstrations, trials, and negotiations. The ideal QMS software provider offers a complete solution to streamline quality management.

Additional aspects to consider when making the final decision include the following.

• Achieving Consensus Among Key Stakeholders: Companies must ensure alignment and consensus among key stakeholders, including quality management and IT departments. This ensures the chosen QMS software adequately addresses cross-functional needs and requirements.
• Review of the Proposed Implementation Plan: Thoroughly assess the proposed implementation plan, including timelines, resource requirements, and milestones. Such implementation plan assessment helps determine its feasibility and alignment with organizational capabilities and constraints.
• Evaluation of Scalability: Companies should evaluate the software’s ability to scale and adapt to future business growth and evolving quality management needs. Ensure that it can accommodate expanding operations and increased complexities over time.
• Flexibility of Contract Terms: Examine the flexibility of contract terms, including provisions for contract adjustments, renewals, and termination. Ensure the agreement remains adaptable to changing circumstances and needs.
• Final Evaluation Meeting: Organize a final evaluation meeting with the decision-making team to discuss all findings, assessments, and analyses. Facilitate a comprehensive review and ensure everyone is aligned before making the final decision.

The following sections will delve deeper into various aspects to consider during the QMS software selection process. The sections below elaborate on the features and characteristics of good QMS software, additional factors to consider, questions to ask QMS software vendors and risks of choosing the wrong eQMS.

What More to Consider When Selecting QMS Software?

When selecting QMS software, companies should consider factors that align with their quality management needs and objectives.

Key considerations include the eQMS software’s functionality, customer support, compliance with requirements, and the ability to integrate with other systems, among others.

What Features Should You Look for in QMS Software?

Some of the features companies should look for in QMS software are described below.

• Out-Of-The-Box Workflows: Out-of-the-box workflows are preconfigured workflows that guide users through quality management processes. Preconfigured workflows accelerate system implementation and adoption, help save time, and ensure regulatory compliance and consistency.
• Electronic Signatures: Electronic signatures are digital representations of handwritten signatures used to authenticate documents in electronic format. Modern QMS software must provide FDA 21 CFR Part 11 and EU GMP Annex 11-compliant electronic signatures to enable secure and compliant process control.
• Audit Trails: Audit trails are chronological records that document every action taken within a system. Time-stamped audit trails within the QMS software ensure accountability and data integrity.
• Reminders and Email Notifications: Choose software with automatic reminder and notification functionalities to keep users informed and ensure timely action on tasks.
• Data Visibility: Opt for QMS software that offers data visibility features, including exporting data and generating quality Key Performance Indicator (KPI) reports.
• User Interface and Usability: Prioritize QMS software with an intuitive user interface and usability features to enhance user adoption and productivity.
• Security Features: Look for software with strong security features. Key features include user access control, multi-factor authentication (MFA), and unique user identification (ID). These security features safeguard sensitive information and ensure compliance with data protection requirements.

Moreover, companies must ensure that the QMS software offers all the necessary quality management modules that align with their organizational needs and meet customer and regulatory requirements.

What Characteristics Define Good eQMS Software?

The characteristics of good eQMS software are as follows.

• Software Vendor’s Industry Experience: The QMS software should be provided by a vendor with industry experience. Good eQMS software offers specialized solutions tailored to the unique needs and requirements of specific industries. Choose an eQMS developed by vendors with extensive industry experience relevant to your field. For example, SimplerQMS is designed specifically for the Life Science industry.
• Deployment/Hosting Options: QMS software vendors offer various deployment options to accommodate organizational preferences and requirements, including cloud-based and on-premise hosting. Choose a QMS solution that offers deployment options aligned with your company’s preferences.
• Configuration Possibilities: Some companies need configurable quality management software. In these cases, companies should choose QMS software that allows such flexibility. Select QMS software that effectively supports the workflows and processes within the company.
• Integration Possibilities: Some companies require QMS software integrations with other systems and tools used within the company. Opt for an eQMS solution that seamlessly integrates with existing systems and tools, enabling efficient data exchange and workflow automation.
• Compliance: Good eQMS software supports compliance with the applicable customer and regulatory requirements. Ensure compliance with industry requirements by choosing an eQMS software that complies with FDA and EU regulations, ISO standards, and other relevant requirements.
• Computer System Validation (CSV): Computer System Validation is the process of ensuring that a computerized system functions as intended. Some companies need QMS software validation. These companies should choose a quality management software vendor that provides a validated solution. Validated QMS software should provide documentation and support to demonstrate the QMS software’s validation as required in highly regulated industries.
• Continuous Improvement and Development: Good eQMS software vendors demonstrate a commitment to continuous improvement and development. Vendors regularly update features and functionalities to meet evolving industry needs and technological advancements. Select an eQMS vendor committed to continuous improvement, ensuring the QMS software remains relevant and effective over time.
• Scalability: QMS software should allow for scalability to accommodate organizational growth and changing needs. Invest in scalable eQMS software that can expand alongside the company without sacrificing performance or efficiency.

What Additional Factors Should Be Considered When Selecting QMS Software?

Some additional factors companies should consider when selecting QMS software are mentioned below.

Total Pricing

Consider the Total Cost of Ownership (TOC) for implementing the QMS software. The TOC is the comprehensive assessment of all direct and indirect costs associated with owning and operating a product or system over its entire lifecycle.

The TOC includes upfront fees, recurring costs, any additional expenses associated with customization or integration, and more.

License Model

Evaluate the licensing model of the software to ensure it aligns with the company’s budget and usage requirements.

A flexible license model ensures optimal utilization of resources and maximizing the QMS software’s value proposition.

Hidden Costs

Consider potential hidden expenses associated with paid features. These features can include implementation, training, ongoing support, hosting fees, and additional storage space requirements.

For example, SimplerQMS provides a comprehensive, all-inclusive solution, including implementation, support, training, hosting, and more, all of which are included in the yearly license cost.

Document Migration

Assess the ease and cost of migrating existing documents and data from the company’s current system to the new QMS software.

Document migration poses challenges, particularly during the shift from paper-based to electronic systems, increasing the risk of data loss.

SimplerQMS addresses this concern by assisting customers in seamlessly migrating their existing documents into the system, ensuring a smooth transition and preserving critical data integrity.

Free QMS Templates

Determine if the software vendor offers a free template package for quality management documents and records.

Free QMS templates are useful during the initial stages of building a QMS or when companies want to review their current templates against best practices during QMS software implementation.

Examples of QMS templates that SimplerQMS provides include quality manuals, standard operating procedures (SOPs), work instructions, and forms.

Below are examples of procedures and instructions that SimplerQMS provides to all customers.

• Document Control
• Change Control
• Complaints Handling
• Nonconformance
• CAPAs
• Education and Training
• Purchasing
• And other procedures and instructions.

Below are examples of templates and forms that SimplerQMS provides to all customers.

• Audit Plan Template
• Change Request Form
• Education and Training Plan Template
• Nonconformance Report Template
• Risk Assessment and Control (RAC-FMEA) Form
• CAPA Form
• Customer Complaint Form
• Supplier Review Form
• And other templates and forms.

Implementation Process

Understand the steps involved in implementing the QMS software, including timeline, resources required, and potential disruptions to daily operations. A well-planned and executed QMS software implementation process is crucial for swiftly adopting the solution and unlocking its full value.

The SimplerQMS implementation process takes an average of 6 weeks and follows a structured, phased approach. The eQMS implementation process encompasses a kick-off meeting, system configuration, document creation and migration, and unlimited personnel training. Once configured and trained, the customer transitions to production.

Customer Support

Evaluate the quality and availability of customer support services provided by the software vendor, including response times, channels of communication, level of expertise, and the answer quality.

Responsive and helpful customer support ensures timely assistance to resolve issues, minimizing downtime and optimizing productivity. Effective support also fosters user satisfaction and confidence in the QMS software.

Customers often praise SimplerQMS’s performance, affordability, and exceptional customer service. For instance, a client testimonial on Capterra praised SimplerQMS for delivering the best customer support experience witnessed in 15 years.

User Training

Consider the availability of training resources and programs to ensure users can effectively utilize the QMS software and maximize its benefits.

Evaluate the available training delivery formats, such as video libraries, workshops, live calls, or in-person training sessions, to accommodate various learning preferences.

Inquire about any limitations on training hours and whether additional training can be purchased if needed. Understanding the amount of training available and the flexibility to extend it ensures users can effectively learn how to utilize the software.

SimplerQMS provides comprehensive training through live calls, videos, and written materials. Customers of SimplerQMS can benefit from an unlimited number of training hours.

User Access Restrictions

Determine the software’s capability to restrict user access to sensitive information within the QMS software. User access restrictions ensure data security and compliance with security requirements.

User access control is useful when different user roles have varying authorization levels. User access restrictions limit access to confidential documents or critical quality documentation to authorized personnel with specific permission levels only.

For example, QMS software by SimplerQMS allows for user restrictions based on company site, project, or document confidentiality levels.

Non-Quality Documents

Assess whether the QMS software can be effectively utilized for managing non-quality-related documents, such as HR documents, marketing, and finance management, among others.

Companies can benefit from using modern QMS software that also allows them to manage non-quality documents. Managing both quality and non-quality documents in one system eliminates scattered storage solutions.

SimplerQMS offers non-quality document management. Our eQMS software eliminates the need for additional document management and storage solutions such as SharePoint, Dropbox, or Google Drive.

Localization and Translation

Companies in need of QMS software in a particular language should prioritize QMS solutions that offer multilingual functionality.

Having the system interface translated into the local languages provides global support and promotes user acceptance. A multi-language solution empowers companies with sites in different regions to configure the system according to their specific language, increasing user engagement.

What Questions Should Be Asked When Evaluating QMS Software?

When evaluating QMS Software, companies should consider asking QMS vendors the following questions.

What happens if I do not have an internet connection?

When selecting a cloud-based QMS software, inquire about offline access options or backup plans in case of internet connection issues.

How do the software’s deployment options align with the IT strategy?

Evaluate how the software’s deployment options align with the company’s IT strategy and infrastructure.

Can the software be easily integrated with existing systems?

Assess the software’s compatibility and ease of integration with existing systems and software applications. For example, compatibility with systems like Customer Relationship Management (CRM), Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Manufacturing Execution System (MES), Product Lifecycle Management (PLM), and more.

How does the vendor ensure compliance with the industry’s regulatory requirements?

Request information on how the vendor ensures compliance with relevant industry regulations, standards, and guidelines that outline requirements for QMS and related processes.

QMS software vendors present compliance with requirements using the User Requirement Specification (URS). The URS outlines the specific needs and expectations of the end-users regarding the software’s functionality and features.

The URS involves detailing how the QMS software supports compliance with requirements such as ISO 9001:2015, ISO 13485:2016, MDR, IVDR, EudraLex Volume 4 GMP, FDA 21 CFR Part 11, 211, and 820, and others.

What are the system’s capabilities for growth and scalability to match the business’s expansion?

Inquire about the scalability and growth capabilities of the system to accommodate your business’s expansion plans.

For example, if the company expands internationally or diversifies its product lines, the QMS software must easily scale to support increased users, data volumes, and geographical locations without sacrificing performance.

What Are the Risks Associated With Choosing the Wrong eQMS?

Below are the key risks of choosing the wrong QMS software which can be avoided by following the QMS software selection steps.

It is important to note that companies should perform a risk assessment related to the eQMS. A proper risk assessment identifies potential risks associated with choosing the wrong QMS software and helps define the company’s User Requirements Specification (URS).

Noncompliance With Requirements

Not clearly understanding the company’s customer and regulatory requirements can lead to selecting software that does not address specific compliance and quality management needs.

Utilizing QMS software that is not compliant with applicable requirements can result in regulatory violations, customer dissatisfaction, and increased operational risks. 

Companies should thoroughly document and analyze all applicable requirements to avoid this risk. Companies should also involve key stakeholders from relevant departments to ensure comprehensive coverage of all needs and objectives.

Inefficient Quality Processes

Choosing the wrong eQMS can result in inefficient quality processes. The QMS software may not align with the company’s workflow or lack essential features. Inefficient processes can lead to wasted time, manual workarounds, and reduced productivity.

To avoid this risk, companies should thoroughly assess the QMS software’s compatibility with existing processes. Schedule demos with multiple vendors to explore a diverse range of features, functionalities, and user interfaces, allowing for a more informed comparison and evaluation.

Limited Scalability

An eQMS that lacks scalability can pose risks to companies as they grow and evolve. Without the ability to scale the QMS software to accommodate increasing data volumes, users, or business complexities, companies may face limitations in managing quality processes effectively.

Companies should prioritize eQMS solutions that can accommodate increasing data volumes with additional storage space and expanding user numbers.

Data Security Breaches

Inadequate data security features in the QMS software can increase the risk of data breaches and unauthorized access to sensitive information. Without robust security measures, such as multifactor authentication (MFA) and access controls, companies are vulnerable to cyber threats and data theft.

Companies should select QMS software with robust access controls, multifactor authentication, single sign-on, and a time-stamped audit trail, among other features.

Missing an Industry-Specific eQMS Solution

The absence of tailored demonstrations during the eQMS selection process can lead to the implementation of a system that is not well-suited to your industry’s specific quality management needs.

To avoid this risk, it is essential to provide vendors with detailed use case scenarios that reflect your operational requirements before purchase. Insist on customized demonstrations that address these scenarios to evaluate the effectiveness of an eQMS and ensure it aligns with your specific needs.

Choosing QMS Software That Does Not Support the Whole Company

Failure to include key stakeholders, like the IT department, in the QMS selection process can result in implementing QMS software that does not meet the needs of specific company departments.

Excluding stakeholders may result in resistance to QMS software adoption, implementation challenges, and non-compliance with specific requirements.

Representatives from all relevant departments should be involved in the QMS software selection process to gather input on specific needs and preferences.

How Much Does QMS Software Cost?

The price of QMS software varies depending on several factors, such as the number of users, included QMS modules and features, and the chosen license types and quantity.

QMS software prices usually start at $13,000 for a company with 5 to 10 employees. The price range for QMS software can vary from $25,000 to $100,000 for companies with 50 to 200 employees.

The SimplerQMS pricing structure is based on the number and types of licenses purchased. The yearly license cost includes all QMS modules, system implementation, user training, ongoing support, validation, and cloud hosting.

For detailed pricing information on SimplerQMS features and services, please visit our dedicated pricing page.

What Are the Hidden Costs of QMS Software?

Some of the commonly hidden costs when implementing QMS software are described below in more detail.

• Implementation: Costs associated with setting up and configuring the QMS software to align with the company’s processes.
• Training: Expenses related to training employees on how to use the QMS software effectively.
• Extra modules: Additional costs for implementing QMS modules beyond the basic package.
• Validation: Expenses with validating the QMS software to ensure compliance with regulatory requirements when the vendor does not validate the QMS software.
• Hosting: Charges for hosting the QMS software on a server or cloud platform.
• Storage: Costs related to additional data storage space within the QMS software if needed.
• Document migration: Expenses associated with migrating existing documents and data into the QMS software.
• Support: Costs for ongoing technical support and maintenance provided by the QMS software vendor beyond the initial implementation phase.

SimplerQMS offers a license-based pricing model that includes all QMS modules, implementation, user training, validation, hosting, document migration, and ongoing support for one price, with no hidden costs.

The system offers an adaptable storage solution. It starts with a base 50 GB capacity and allows for the purchase of additional storage if needed. The storage space automatically increases with the purchase of additional user licenses, providing 10 GB per additional Single User License and 30 GB per additional Shared License.

What Are the Best QMS Software Solutions to Choose From?

The best examples of QMS software solutions for Life Science companies are the following.

• SimplerQMS: SimplerQMS is a fully validated QMS software tailored for Life Science companies, offering extensive module options and seamless integration with Microsoft Office.
• Qualio: Qualio is designed for growing Life Science companies and presents a user-friendly web-based document editor.
• MasterControl: MasterControl is ideal for large Life Science enterprises, excelling in comprehensive document control and complying with FDA 21 CFR Part 11 regulation.
• TrackWise: TrackWise is tailored for pharmaceuticals, biotech, and more, featuring AI-driven decision-making for proactive quality management.
• Ideagen Quality Management: With a wide array of modules, Ideagen Quality Management stands out for its Microsoft Office integration and e-learning capabilities.
• Greenlight Guru: Cloud-based and focused on MedTech, Greenlight Guru simplifies document workflows with native editing.
• Dot Compliance: Dot Compliance offers AI-driven insights through its assistant, Dottie AI, for Life Sciences companies.
• QT9: QT9 provides a web-based eQMS with over 23 built-in modules for various industries.
• Scilife: Scilife is a QMS validated on the Amazon Web Services platform that offers comprehensive QMS modules tailored to Life Sciences.

The post How to Choose Quality Management Software? appeared first on SimplerQMS.

Medical device startup companies have an essential role in driving the growth and development of the medical device market. According to a report by Statista, the medical device market has a projected annual growth rate of 5.26%, moving towards a market volume of US$609.70 billion by 2028.

Innovative medical device startups analyze healthcare gaps, identifying deficiencies in existing solutions, from diagnostics challenges to therapeutics limitations. The core mission of emerging medical device startups is to create targeted solutions that address these gaps, advancing healthcare technology and improving patient outcomes.

In this article, we will present and discuss the top 12 medical device startup companies to look out for in 2024.

We selected startups based on their significant media coverage due to notable achievements in the medical device industry. Note that the mentioned companies are just the primary examples among numerous new startups advancing healthcare globally.

SimplerQMS provides a fully GAMP 5-validated eQMS solution tailored for Medical Device companies. Discover how our software streamlines quality management and supports compliance by booking a demo with our Quality Solution experts.

The following medical device startups will be examined in greater detail.

• AbCellera
• Bigfoot Biomedical
• BrainsWay
• Ceribell
• Flatiron
• Freespira
• Guardant Health
• MMI
• Natera
• Tempus
• Tivic
• Verily

AbCellera

AbCellera is a Canadian biotechnology startup specializing in antibody discovery. AbCellera was founded in 2012 by Carl Hansen, Veronique Lecault, Kathleen Lisaingo, Daniel Da Costa, and Kevin Heyries.

AbCellera aims to address challenges in antibody research and development in the medical field. The company’s flagship product, a platform to develop first-in-class antibody medicines, is renowned for its high-throughput antibody screening capabilities.

AbCellera operates globally, serving clients in the biopharmaceutical industry, such as Moderna and Lilly.

Additionally, AbCellera has received recognition for its innovative approach, being named by Fierce Biotech as one of the Fierce 15 Biotechnology Companies in 2020.

AbCellera is revolutionizing the medical industry with its innovative antibody discovery platform, as showcased below.

Key facts about the AbCellera.

Bigfoot Biomedical

Bigfoot Biomedical is a United States-based healthcare technology startup manufacturing medical equipment. Bigfoot Biomedical specializes in the field of diabetes management.

The medical device startup was founded in 2014 by Jeffrey Brewer and Bryan Mazlish to simplify diabetes management and improve glycemic control for people requiring insulin therapy.

Bigfoot Biomedical’s flagship product, the Bigfoot Unity Diabetes Management System, is renowned for its real-time integration of continuous glucose monitoring (CGM) data to provide personalized insulin dose recommendations.

Bigfoot Biomedical currently operates in the United States and partners with companies such as Lilly and Abbott.

Additionally, Bigfoot Biomedical has earned recognition as one of Fast Company’s World’s Most Innovative Companies in the medical device category for 2023.

Bigfoot Biomedical is transforming the medical industry with its advanced Diabetes management system, as showcased below.

Key facts about Bigfoot Biomedical.

BrainsWay

BrainsWay is an Israeli medical technology startup specializing in neuromodulation. BrainsWay was founded in 2003 by Avner Hagai, Yiftach Roth, David Zacut, and Abraham Zangen to address mental health issues through innovative technologies in the medical field.

The company’s flagship product, the Deep Transcranial Magnetic Stimulation (Deep TMS) system, is renowned for its non-invasive approach that uses magnetic fields in treating various neurological and psychiatric disorders, such as major depression, anxious depression, obsessive-compulsive disorder, and smoking addiction.

BrainsWay operates in over 30 countries with more than 800 providers, including licensed independent clinicians and hospitals.

Additionally, BrainsWay has received recognition for its innovative contributions, winning awards such as the Fast Company’s annual list of the World’s Most Innovative Companies for 2023.

BrainsWay is revolutionizing the medical industry with its innovative Deep TMS system, as showcased below.

Key facts about BrainsWay.

Ceribell

Ceribell is a United States-based medical technology startup specializing in neurology, particularly in the field of electroencephalogram (EEG) monitoring. Ceribell was founded in 2014 by Jane Chao, Josef Parvizi, and Chris Chafe.

Ceribell aim is to improve the diagnosis and management of epilepsy and other neurological conditions by providing continuous bedside EEG monitoring in acute care settings.

Ceribell’s flagship product, the Ceribell Point-of-Care EEG, is renowned for its portability and easy deployment. Ceribell Point-of-Care EEG offers individuals with no background in EEG the ability to detect and rule out suspected seizures with remarkable accuracy.

Ceribell currently operates in the United States and primarily serves hospitals and healthcare institutions seeking advanced tools for neurological monitoring.

Additionally, Ceribell has received recognition for its innovative approach, winning multiple awards at the Medical Design Excellence Awards (MDEAs), including a gold medal in Testing and Diagnostic Products and Systems, a silver in NonSurgical Hospital Supplies and Equipment, and the Best in Show award.

Ceribell is transforming the medical industry with its advanced Ceribell Point-of-Care EEG, as showcased below.

Key facts about Ceribell.

Flatiron

Flatiron is a United States healthcare technology startup specializing in real-world data and real-world evidence solutions for oncology.

Flatiron was founded in 2012 by Nat Turner and Zach Weinberg to revolutionize cancer care by leveraging real-world data to improve clinical decision-making, drug development, and research.

The company’s flagship product, a cloud-based oncology software and analytics, is renowned for its ability to aggregate and analyze data from electronic health records (EHRs) of millions of cancer patients, providing valuable insights into treatment patterns, patient outcomes, and disease progression.

Flatiron currently operates in the United States, Germany, Japan, and the United Kingdom and primarily serves oncology clinics, hospitals, pharmaceutical companies, and research institutions seeking to improve the understanding and treatment of cancer.

Flatiron is revolutionizing the medical industry with its innovative cloud-based oncology platform, as showcased below.

Key facts about Flatiron.

Freespira

Freespira is a United States-based healthcare startup specializing in the mental health and digital therapeutics industry. Freespira was founded in 2013 by Debra Reisenthel and Beth Siegelman to address the specific need for effective treatment of panic attacks and panic disorder.

Freespira’s flagship product, the Freespira breathing monitoring system, is renowned for its unique feature of providing guided respiratory exercises to help individuals manage and overcome panic attacks. This innovative digital therapeutic approach has proven to be effective in treating panic disorder, offering a non-pharmacological solution.

Freespira operates in the United States, providing its digital therapeutic solution to a diverse clientele, including individuals suffering from panic attacks and related disorders, such as veterans.

Additionally, Freespira has received recognition for its innovative approach, winning awards such as the Fast Company’s award for Most Innovative Companies in 2023.

Freespira is revolutionizing the medical industry with its modern digital breathing monitoring system, as showcased below.

Key facts about Freespira.

Guardant Health

Guardant Health is a United States precision medicine startup specializing in liquid biopsy tests for detecting and monitoring cancer. The company was founded in 2012 by Helmy Eltoukhy and Amir Ali Talasaz.

Guardant Health aims to revolutionize cancer care by making comprehensive cancer testing accessible through a simple blood draw. This groundbreaking liquid biopsy provides oncologists with valuable insights for personalized cancer treatment, allowing for early detection and monitoring.

The company’s flagship product, the Guardant360 CDx, is renowned for its ability to analyze multiple genes and mutations from a single blood sample, providing valuable insights into a patient’s specific cancer type, genetic profile, and potential treatment options.

Guardant Health currently operates in over 60 countries and serves diverse customers, including oncologists, hospitals, and pharmaceutical companies.

Additionally, Guardant Health has received recognition for its innovative approach, winning awards such as the Oncology Product Innovation of the Year conferred by Healthcare Medtech Asia Awards in 2023.

Guardant Health is revolutionizing the medical industry with its innovative Guardant360 CDx, as showcased below.

Key facts about Guardant Health.

MMI

MMI (Medical Microinstruments) is an Italian startup specializing in the medical device industry, particularly in developing microsurgical instruments. MMI was founded in 2015 by Giuseppe Prisco, Hannah Teichmann, and Massimiliano Simi. MMI aims to address the need for advanced microsurgical tools in the medical field.

The MMI’s flagship product, the Symani Surgical System, is renowned for its wristed instruments that offer enhanced dexterity and maneuverability, allowing surgeons to perform complex microsurgical procedures with greater control and precision.

MMI currently operates globally and serves a diverse clientele, including surgeons specializing in breast cancer, lymphedema, head and neck cancer, and trauma.

Additionally, MMI has received recognition for its innovative approach, winning awards such as the Fast Company’s award for Most Innovative Companies in 2023.

MMI is transforming the medical industry with its first-of-its-kind robotic platform, Symani Surgical System, as showcased below.

Key facts about MMI.

Natera

Natera is a United States-based healthcare startup specializing in genetic testing and diagnostics, particularly in reproductive health and oncology. Natera was founded in 2004 by Matthew Rabinowitz and Jonathan Sheena to address the need for advanced and accurate genetic testing solutions.

The company’s flagship product, Panorama, is a non-invasive prenatal test (NIPT) renowned for its accuracy in detecting genetic abnormalities during pregnancy.

Natera’s innovative testing services extend to various areas, including preconception planning, oncology, and organ transplant monitoring.

Natera operates globally in collaboration with companies such as BGI and Unilabs. Natera’s customers include pregnant women, physicians, genetic counselors, oncologists, and transplant centers.

Additionally, Natera has received recognition for its innovative approach, winning awards such as the Fierce Life Sciences Innovation Award in 2021.

Natera is modernizing the medical industry with its advanced Panorama NIPT, as showcased below.

Key facts about Natera.

Tempus

Tempus is a United States precision medicine startup specializing in artificial intelligence (AI)-powered analytics platform for oncology.

Tempus was founded in 2015 by Eric Lefkofsky to transform cancer care by improving patient data analysis through AI to deliver personalized treatment options and improve clinical decision-making.

The company’s flagship product, the Tempus AI platform, is renowned for its ability to aggregate, analyze, and interpret vast amounts of clinical and molecular data from various sources. The platform provides physicians and researchers with comprehensive insights to guide personalized care plans for cancer patients.

Tempus currently operates in more than 20  countries and primarily serves oncology clinics, hospitals, pharmaceutical companies, and research institutions seeking to leverage AI and data analytics to advance cancer research and improve patient outcomes.

Tempus is revolutionizing the medical industry with its modern AI-powered analysis platform, as showcased below.

Key facts about Tempus.

Tivic

Tivic Health is a United States healthcare technology startup specializing in bioelectronic medicine for treating inflammatory sinus conditions reducing sinus pain, sinus headaches, and congestion. Tivic Health was founded in 2016 by Jennifer Ernst to address the need for effective and drug-free solutions for sinus pain and congestion relief.

Tivic’s flagship product, the ClearUP, is renowned for its non-pharmacological approach of utilizing low-level electrical current to penetrate deeply through tissue to alleviate sinus pain.

Tivic currently operates in the United States and primarily serves individuals experiencing chronic sinusitis and other inflammatory conditions seeking non-invasive treatment options.

Additionally, Tivic Health has received recognition for its innovative approach, winning awards such as the Top 100 Healthcare Technology Companies of 2021.

Tivic is revolutionizing the medical industry with its innovative ClearUP device, as showcased below.

Key facts about Tivic.

Verily

Verily is a United States-based life sciences and healthcare technology startup specializing in precision biomedical research and data analytics for disease prevention and treatment. Verily was founded in 2015 by Andy Conrad to leverage technology to address complex challenges in healthcare.

The company’s flagship product, the Verily precision health platform, is renowned for its comprehensive approach to collecting and analyzing health data to advance medical research and improve patient outcomes. Verily’s innovative platform integrates various technologies, including wearables, sensors, and data analytics software, to generate insights into human health and disease.

Verily operates globally and collaborates with healthcare organizations and research institutions with a focus on precision health and personalized medicine.

Additionally, Verily received recognition for its advanced approach, winning awards such as the Top 100 Healthcare Technology Companies of 2022.

Verily is revolutionizing the medical industry with its innovative precision health platform, as showcased below.

Key facts about Verily.

How Can SimplerQMS Help Position Medical Device Startups for Success?

SimplerQMS helps position medical device startups for success by offering a robust Electronic Quality Management System (eQMS) software tailored to their unique needs.

An Electronic Quality Management System (eQMS) is a digital solution designed to automate and streamline quality processes within businesses. The eQMS encompasses a range of capabilities, including document control, change management, audit management, and training records, all integrated into a single system.

SimplerQMS provides QMS software for medical device companies that enables startups to streamline and automate quality management processes, fostering an efficient workflow. The software also supports compliance with regulatory standards and regulations that outline requirements for QMS, such as ISO 13485:2016, FDA 21 CFR Part 820, MDR and IVDR, and more.

How Do New Medical Device Companies Benefit From Using an eQMS?

New medical device companies can have several benefits when using an Electronic eQMS, such as the following.

• Regulatory Compliance: Utilizing an eQMS helps ensure new medical device companies comply with regulatory requirements from regulatory bodies like the FDA and EMA.
• Centralized Data Management: QMS software provides a single repository for all quality-related data, improving organization, accessibility, and decision-making.
• Improved Collaboration: A centralized eQMS platform enables seamless teamwork and knowledge sharing across departments, even in remote settings.
• Faster Time to Market: Electronic QMS streamlines quality processes, like design controls and change management, facilitating faster product development and launch.
• Error Reduction: Implementing an eQMS minimizes human error and inconsistencies by automating workflows and providing reminders and notifications.
• Document Control: QMS software streamlines document control processes by automating the creation, review, approval, distribution, and archiving of documents, ensuring compliance and enhancing efficiency in a centralized platform.
• Change Management: The system streamlines the process of implementing changes, ensuring that modifications to procedures, designs, or materials are well-documented and approved, preventing unauthorized alterations.
• Efficient Training Management: New companies benefit from eQMS’s ability to organize and track employee training, ensuring that staff is adequately trained on relevant processes.
• Scalability for Growth: Digital QMS solutions are adaptable, allowing for expansion alongside the company ensuring a robust system as the company evolves.

When Should Medical Device Startups Consider Implementing QMS Software?

Medical device startups should consider implementing an eQMS once they have established or are actively developing the quality management system and its documentation.

More specifically, medical device startups should consider implementing an eQMS when facing the following:

• Needing to improve communication and collaboration within the departments.
• Seeking to automate and streamline QMS processes for improved efficiency and cost reduction.
• Aiming to improve compliance efforts with regulations, standards, and guidelines.
• Requiring better visibility into quality management data.
• Needing a scalable and flexible solution to accommodate company growth.

Although there is no perfect time, the earlier a medical device startup implements an eQMS, the greater the benefits it can experience. Startups implementing QMS software early on establish a strong foundation for quality and compliance.

SimplerQMS provides fully validated QMS software according to GAMP 5. SimplerQMS supports all QMS processes, such as document control, change management, training, supplier management, audit management, nonconformances, and more.

The SimplerQMS software supports companies in achieving compliance with regulatory standards and regulations that outline the requirements for QMS, such as ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820, by providing comprehensive QMS process support.

Learn how SimplerQMS can streamline your quality management processes and compliance efforts by booking a demo with our Quality Solution Consultants.

The post Top 12 Medical Device Startups to Look Out For in 2024 appeared first on SimplerQMS.

The M-Files software can also be used as an Electronic Quality Management System (eQMS).

M-Files provides a flexible and configurable platform that enables companies to manage quality processes, documentation, and compliance requirements efficiently.

M-Files offers features that support the core components of an eQMS, such as document control, process automation, electronic signatures, audit trails, enterprise-level security, and more.

SimplerQMS has utilized M-Files as the foundational platform, configuring and building upon it to create a quality management system software tailored for the Life Sciences industry.

SimplerQMS has leveraged M-Files to develop integrated Life Science QMS modules, streamlining document control, change control, nonconformance, and deviation management, training management, and other quality management processes.

SimplerQMS integrates with Microsoft Entra ID (formerly Azure Active Directory) for user authentication and authorization, and it is hosted on Microsoft Azure cloud, ensuring secure and reliable access.

By combining M-Files and Microsoft technologies, SimplerQMS delivers a more streamlined and secure quality management experience, ensuring more efficient operations and helping ensure compliance.

SimplerQMS is a fully GAMP 5-validated quality management software designed specifically for Life Science companies. Learn how our software facilitates quality management and compliance efforts by booking a demo with our Quality Solution experts.

The following will be examined in greater detail.

• What Is M-Files?
• What Is M-Files QMS (Quality Management System)?
• What Are the Benefits of M-Files QMS?
• How SimplerQMS Uses M-Files QMS Tools?
• How SimplerQMS Uses M-Files and Microsoft Technologies?
• What Is the Role of Specialized M-Files Based QMS Software?

What Is M-Files?

M-Files is a document management software that offers a cloud-based, metadata-driven platform. The platform enables companies to manage digital data and documents in a single repository.

The M-Files document management solution is designed to automate business processes and enforce information control.

The M-Files software solution is developed and provided by its namesake company, M-Files, a global company based in Finland.

M-Files is a global leader in information management solutions. M-Files employs over 500 individuals. It collaborates with over 300 partners worldwide. M-Files serves more than 5,000 customers. Its operations extend across more than 100 countries.

M-Files is used by small, medium, and large companies worldwide, including Bahlsen in Germany, Safran in France, Crowe in the United States, and others.

What Is M-Files QMS (Quality Management System)?

M-Files QMS (Quality Management System) is a software solution designed to manage and control quality documents, procedures, records, and processes.

M-Files QMS leverages the core capabilities of M-Files’ document management system, offering features tailored for quality management.

M-Files QMS is used for managing and controlling various aspects of quality and compliance within companies, including document management, change control, training, nonconformance management, audit management, and more. The system allows streamlined document management, process automation, and workflow control.

SimplerQMS provides an Electronic Quality Management System (eQMS) built on the M-Files quality management platform. SimplerQMS enhances the robust document management and workflow capabilities of the M-Files platform to offer a comprehensive and specialized eQMS solution for Life Science companies.

What Are the Benefits of M-Files QMS?

The benefits of M-Files QMS include, but are not limited to, the following.

• Robust Document Management System
• Full Integration With Microsoft Office   
• Enterprise Level Security

Robust Document Management System

M-Files QMS serves as a centralized repository for all quality-related documents, fostering an environment of improved accessibility and control. The system helps eliminate information silos and outdated versions with a single source of truth for SOPs, procedures, forms, and records.

M-Files document management capabilities include customizable metadata for granular traceability and searchability of documents. M-files offers automated workflows to streamline review, approval, and signature processes.

Full Integration With Microsoft Office

M-Files QMS integrates seamlessly with the Microsoft Office suite, including Word, Excel, and PowerPoint.

The integration enables direct document editing within Microsoft applications. Changes in documents automatically synchronize with the central repository, eliminating burdensome download-edit-upload cycles.

Enterprise Level Security

M-Files QMS provides a robust security framework. Tamper-proof audit trails meticulously track every action, and electronic signatures further support accountability and regulatory compliance.

M-Files QMS complies and is certified to industry requirements such as ISO 9001:2015 (quality management system), ISO 27001:2022 (information security), ISO 27017:2015 (security techniques for cloud services), ISO 27018:2019 (protection of personally identifiable information), ISO 22301:2012 (business continuity management systems), SOC 2 and 3 (controls and systems security).

M-Files QMS supports achieving compliance with several requirements, including FDA 21 CFR part 11, Eudralex Vol 4 Annex 11, and HIPAA (Health Insurance Portability and Accountability Act), among others.

How SimplerQMS Uses M-Files QMS Tools?

SimplerQMS utilizes the tools provided by M-Files QMS to develop quality management modules designed for the Life Science QMS needs. SimplerQMS’s approach enables the creation of a comprehensive quality management system tailored to the unique requirements of companies in the Life Sciences industry.

Below are some of the key quality management processes where SimplerQMS utilizes M-Files QMS tools to suit the needs of Life Science companies.

• Document Control
• Change Control Management
• Training Management
• Nonconformance and Deviation Management
• CAPA Management
• Supplier Management

Document Control

SimplerQMS employs M-Files document management capabilities to control all quality-related documents. From SOPs and records to supplier information and training plans, everything resides in a single, secure location, readily available for authorized personnel.

SimplerQMS provides document control software that streamlines and automates quality-document activities, such as document review and approval process, document versioning, signing documents with electronic signatures, and more.

SimplerQMS system also integrates with Microsoft Office applications, such as Word, Excel, and PowerPoint. The integration allows documents within the system to be edited in the familiar Microsoft applications.

Change Control Management

SimplerQMS change control management module provides the foundation for effectively managing changes. Proposed changes are documented, reviewed, and approved following automated workflows.

SimplerQMS software streamlines change control management processes from initial change request creation to final approval and successful implementation.

All modifications to documents are automatically recorded within the system, complete with timestamps. These comprehensive records ensure accountability and facilitate compliance.

Training Management

SimplerQMS facilitates the management of employee training and the organization of training material. The system helps ensure employees complete training and stay up to date on essential knowledge by streamlining and automating essential tasks like training activity assignments, notifications, reminders, and training record creation.

The SimplerQMS training management capabilities enable training managers to create learning rules, assign relevant training materials, automate training assignments, track employee training progress, and more.

Nonconformance and Deviation Management

SimplerQMS software offers nonconformance management and deviation management modules.  

The nonconformance management module is designed to handle events where a product, process, or service does not meet specified requirements or standards.

Similarly, the deviation management module outlines how to control deviations in a structured and organized manner, including the event’s identification, reporting, investigation, resolution, and documentation.

All QMS modules are interlinked, allowing companies to escalate and relate nonconformance and deviations to CAPA with just a few clicks.

CAPA Management

SimplerQMS enables effective management of the CAPA lifecycle, from documenting root cause analysis to scheduling CAPA effectiveness checks.

The SimplerQMS CAPA management module simplifies the documentation and review process of quality events, facilitating continuous improvement efforts. The CAPA management module supports the development and implementation of actions aimed at preventing the recurrence of similar issues in the future.

The system also facilitates monitoring CAPA status with customizable views.

Supplier Management

SimplerQMS simplifies the management of supplier documents, contracts, qualification status, audits, and approved supplier lists (ASL).

Life Science companies use the SimplerQMS supplier management module to manage suppliers, from initial qualification and risk assessment to continuous monitoring and performance evaluation.

How SimplerQMS Uses M-Files and Microsoft Technologies?

SimplerQMS uses both M-Files and Microsoft technologies to create a comprehensive and secure Electronic Quality Management System (eQMS) tailored for the Life Sciences industry.

SimplerQMS uses the M-Files platform as its core foundation for document management and quality management processes. M-Files provides a versatile and robust document management system that supports metadata-driven document handling, version control, and process automation.

M-Files tools allow SimplerQMS to offer specialized modules for document control, change management, employee training, CAPA management, audit management, and supplier management, among others, facilitating effective quality management.

The modules include capabilities for handling controlled documents, managing change controls, planning audits, scheduling risk assessments, and more.

Broad quality management support helps Life Science companies ensure compliance with several Life Science requirements, such as ISO 9001:2015 and ICH Q10.

SimplerQMS integrates with Microsoft Entra ID (formerly Azure Active Directory) for secure user authentication and authorization.

Microsoft Entra ID provides single sign-on (SSO) capabilities and enforces strong authentication protocols like multi-factor authentication (MFA) logins, significantly reducing the risk of unauthorized access or compromised credentials.

SimplerQMS utilizes Microsoft Azure for cloud hosting, benefiting from Azure’s scalability, reliability, and security features. Azure hosting ensures that SimplerQMS offers its eQMS as a Software as a Service (SaaS), providing customers with easy access to their QMS without needing extensive IT infrastructure.

Microsoft Azure provides robust disaster recovery capabilities and supports compliance with data residency requirements, such as ISO 27001:2022, ISO 27017:2015, ISO 27018:2019, and ISO 27701:2019.

The SimplerQMS technology platform is built on established, proven technologies and complies with the industry requirements, empowering Life Science companies worldwide to confidently manage quality systems. SimplerQMS complies with Eudralex Volume 4 GMP Part I, Eudralex GMP Annex 11, FDA 21 CFR Part 11, 211, 212, and 820, and ISO 13485:2016.

Additionally, SimplerQMS is fully validated according to GAMP 5 and supports achieving compliance with Life Science-related requirements, such as ISO 13485:2016, ISO 15189:2022, 21 CFR Part 210, 211, 212 and 820, ICH Q10, and more.

Moreover, M-Files complies with ISO 27001:2022, ISO 27017:2015, ISO 27018:2014, ISO 22301:2012, ISO 9001:2015, SOC 2 and SOC 3, GDPR, SOX-404, and FIPS 140-2 Level 2.

And Microsoft Azure and Entra ID complies with ISO 27001:2022, ISO 27017:2015, ISO 27018:2014, ISO 22301:2012, ISO 9001:2015, SOC 1, SOC 2 and SOC 3, and GDPR.

What Is the Role of Specialized M-Files Based QMS Software?

Specialized M-Files-based Quality Management System (QMS) software plays an essential role in addressing the unique needs of specific industries, providing tailored solutions for effective quality management.

Regular M-Files QMS serves a broad range of applications, providing a generic framework that may require additional customization to meet industry-specific compliance requirements.

In contrast, specialized M-Files-based QMS is purpose-built, incorporating industry-specific modules and workflows from the outset. Specialization ensures a more seamless integration into the existing processes of targeted industries, addressing their regulatory requirements more precisely.

SimplerQMS is a notable example, providing a specialized Life Science QMS software by utilizing M-Files features to build quality management process support designed for pharmaceutical, medical device, biotechnological, Contract Research Organizations (CRO), Contract Development and Manufacturing Organizations (CDMO), and other related industries.

What Is the Difference Between M-Files QMS and SimplerQMS?

The difference between M-Files QMS and SimplerQMS is the level of specialization, additional services, and industry-specific focus.

M-Files QMS provides a comprehensive set of tools for document management, workflow automation, and collaboration across various industries. M-files QMS solution is adaptable to different sectors and requires additional customization to meet industry-specific needs.

On the other hand, SimplerQMS utilizes the M-Files platform to offer a specialized QMS tailored explicitly for Life Science industries.

SimplerQMS goes beyond just utilizing the M-Files tools and offers added value through a comprehensive suite of services.

SimplerQMS solution includes a personalized implementation process, ensuring a seamless integration into the existing processes of Life Science companies. Comprehensive user training is provided to teach users the necessary knowledge and skills to navigate specialized software, ensuring effective utilization.

SimplerQMS also takes charge of system validation, relieving customers from the need to allocate additional resources. SimplerQMS system is fully validated according to GAMP 5 and kept permanently validated. Moreover, ongoing support is offered to address any queries or issues, providing QMS software that supports its effective use.

SimplerQMS uses M-Files QMS and Microsoft technologies to offer a tailored quality management solution for the Life Sciences industry. SimplerQMS provides all QMS modules, system implementation, user training, full validation, and ongoing customer support.

Experience how SimplerQMS can optimize your quality management processes and support your compliance. Book a demo with our expert Quality Solution Consultants to see SimplerQMS in action.

The post M-Files QMS (Quality Management System) appeared first on SimplerQMS.

Examples of EU MDR Class I medical devices include hospital beds, corrective glasses, and thermometers. MDR Class IIa medical devices contain catheters, hearing aids, and surgical clamps. MDR Class IIb medical devices contain contact lenses, surgical lasers, and defibrillators. MDR Class III medical devices include hip-joint implants, prosthetic heart valves, and aneurysm clips.

The EU MDR, officially known as Regulation (EU) 2017/745, outlines 22 rules to guide the appropriate categorization of medical devices based on their potential risks and intended use.

Resembling the EU MDR, the United States Food and Drug Administration (FDA) also classifies medical devices based on their potential risk to safety. However, instead of 22 specific rules, the FDA uses risk classification and comparisons to similar devices already in the market.

Each EU MDR class establishes specific regulatory requirements medical devices must comply with, from self-declaration of conformity to periodic safety update reports. Accurately classifying a device ensures following the right approval pathway, saving time and resources.

Quality Management System (QMS) software facilitates the approval process for medical devices under EU MDR. Medical device companies are adopting QMS solutions to streamline quality management, increasing the chances of successful device approval in the European market.

SimplerQMS is a fully GAMP 5-validated QMS software designed to meet the unique needs of medical device companies. Discover how our software streamlines quality management processes and book a demo with one of our quality solution experts.

We will discuss the following topics in more detail:

• What Are EU MDR Medical Device Classes?
• What Is an EU MDR Class I Medical Device?
• What Is EU MDR Class IIa Medical Device?
• What Is EU MDR Class IIb Medical Device?
• What Is EU MDR Class III Medical Device?
• How To Classify Your Medical Device According to EU MDR Classification Rules?
• What Is the Difference Between EU MDR and FDA Medical Device Classification?
• What Are the Different EU MDR Medical Device Regulatory Approval Pathways?
• What Is the Role of eQMS in Facilitating EU MDR CE Marking Regulatory Process?

What Are EU MDR Medical Device Classes?

The EU MDR categorizes medical devices into four classes: Class I, Class IIa, Class IIb, and Class III.

Medical device classes are determined by the potential risk of harm the device presents to the user.

Determining the class of medical devices under the MDR involves following the 22 classification rules outlined in Annex VIII. These rules are a structured approach to assessing the potential risk posed by a device based on various factors.

The risk posed by the device to safety outlines the four classes as follows:

• Class I: Class I medical devices pose a minimal danger to patients and are primarily used for non-invasive procedures and basic functions.
• Class IIa: Class IIa devices have a higher risk potential than Class I but remain moderate.
• Class IIb: Class IIb devices fall between Class IIa and III, posing a significant risk but not as high as life-supporting or long-term implantable devices.
• Class III: Class III medical devices pose the highest potential risk, often supporting vital functions, being implanted for long periods, or used in critical procedures.

The MDR considers body placement and intrinsic characteristics for device classification, as mentioned below.

• Non-invasive: Non-invasive devices work outside the body. Non-invasive devices generally pose lower risks and fall under Class I or Class IIa medical devices, according to the MDR. Examples of non-invasive medical devices are thermometers and stethoscopes.
• Invasive: Invasive devices pierce or enter the body through an opening or its surface. Due to the deeper interaction with the body, invasive devices carry higher risks and typically fall under Class IIb or Class III medical devices. Examples of invasive medical devices are catheters and implants.
• Active: Active devices rely on an external power source like electricity, batteries, or chemicals to function. The active nature and potential impact on bodily systems necessitate increased regulatory oversight, often placing them in Class IIb or Class III medical devices. Examples of active medical devices are pacemakers and insulin pumps.

Furthermore, the duration of use is also considered when classifying medical devices, as follows.

• Transient: Transient devices are intended for continuous use for less than 60 minutes.
• Short-term: Short-term use devices are intended for continuous use between 60 minutes and 30 days.
• Long-term: Long-term use devices are intended for continuous use for more than 30 days.

Understanding the classification of a medical device is essential as it dictates the regulatory requirements medical devices need to comply with. Determining the correct class also ensures patient safety and avoids compliance issues.

What Is an EU MDR Class I Medical Device?

Class I medical devices under the EU MDR are considered low-risk devices. Class I medical devices are usually non-invasive and for transient use. Consequently, due to the low-risk profile, Class I medical devices have less stringent regulatory requirements compared to higher-risk devices.

Class I medical devices are subdivided based on device-specific features.

Class I medical devices can be placed on the market in sterile condition (Class Is), with a measuring function (Class Im), or reusable (Class Ir), as explained below.

• Class Is: Class Is indicates a sterile device, for example, a personal protection kit.
• Class Im: Class Im indicates the medical device has a measuring feature, for instance, thermometers.
• Class Ir: Class Ir comprehends a reusable device, for example, surgical instruments.

The certificated Class I medical devices comprised 12% of all medical devices, according to the European Database on Medical Devices (EUDAMED), in 2023.

What Are EU MDR Class I Medical Device Examples?

Examples of medical devices in Class I are given below.

• Surgical instruments
• Manual stethoscope
• Sterile urine bags
• Corrective glasses and frames
• Manual wheelchairs
• Plasters
• Thermometers
• Bedpans
• Hospital beds
• Personal protection kits
• Weighing scale
• Endoscopes

What Is EU MDR Class IIa Medical Device?

Class IIa medical devices present moderate risk under EU MDR, posing a higher potential for harm than Class I medical devices but lower than Class IIb and Class III medical devices.

Class IIa medical devices are usually surgically invasive devices intended for transient and short-term use. Active medical devices intended for diagnosis and monitoring are also classified as Class IIa.

Of all approved medical devices on the market, 44% are considered Class IIa, according to the EUDAMED in 2023.

What Are EU MDR Class IIa Medical Device Examples?

Examples of medical devices in Class IIa are given below.

• Surgical clamps
• Diagnostic software
• Hearing aids
• Catheters
• Infusion pumps
• Ultrasonic diagnostic equipment

What Is EU MDR Class IIb Medical Device?

Class IIb medical devices represent a significant medium risk, bridging the gap between moderate-risk Class IIa and high-risk Class III medical devices.

Class IIb medical devices are usually implantable and long-term surgically invasive devices with a greater impact on patient health than lower classes.

Of all the certified medical devices, 33% are considered Class IIb, according to the EUDAMED in 2023.

What Are EU MDR Class IIb Medical Device Examples?

Examples of medical devices in Class II are given below.

• Blood bags
• Intensive care monitoring equipment
• Ventilators
• Implantable dental devices
• Long-term corrective contact lenses
• Short-term implantable catheters
• Surgical lasers
• High-intensity focused ultrasound equipment

What Is EU MDR Class III Medical Device?

Class III medical devices under the EU MDR represent the highest risk category. Class III medical devices encompass active implantable medical devices and long-term surgically invasive medical devices that directly or indirectly support life.

The high-risk nature of Class III medical devices requires strict regulations to ensure patient safety and device effectiveness.

Certificated Class III medical devices comprised 11%, according to the EUDAMED, in 2023.

What Are EU MDR Class III Medical Device Examples?

Examples of medical devices in Class III are given below.

• Defibrillators
• Prosthetic heart valves
• Implanted prosthetics
• Cardiovascular catheters
• Automated external defibrillators
• Aneurysm clips

How To Classify Your Medical Device According to EU MDR Classification Rules?

The EU MDR outlines the classification rules for medical devices in Chapter III of Annex VIII, which details the criteria for assigning devices to their appropriate risk class.

The EU MDR utilizes 22 classification rules grouped into four distinct categories, as listed below.

• Non-invasive devices
• Invasive devices
• Active devices
• Special rules

Non-invasive Devices

Non-invasive medical device classification comprehends rules 1 to 4.

Non-invasive device rules cover devices that do not penetrate the body’s natural surface and are considered low-risk due to minimal interaction with the body. The rules assess the device’s intended use, materials, and duration of use.

Medical devices covered by rules 1 to 4 are generally considered Class I medical devices. However, Class IIa, Class IIb, and Class III medical devices can also be used for non-invasive devices.

Invasive Devices

Invasive medical device classification encompasses rules 5 to 8.

Invasive device rules apply to devices breaching the body’s surface, which pose a more significant risk than non-invasive ones. The rules consider invasiveness level, intended use, and potential for infection or tissue damage.

Medical devices under rules 5 to 8 are mostly considered Class IIa, Class IIb, and Class III medical devices. Still, some devices categorized under these rules are classified as Class I.

Active Devices

Active medical device classification comprises rules 9 to 13.

Active device rules concern medical devices relying on external power to operate, such as pacemakers and insulin pumps. The rules highlight energy source hazards, software safety, and the potential for malfunction.

Medical devices comprised in rules 9 to 13 can pertain to Class I, Class IIa, Class IIb, and Class III, depending on body placement and duration of use. For example, medical devices intended to illuminate the patient’s body in the visible spectrum are classified as Class I, while software designed to monitor physiological processes is classified as Class IIa.

Special Rules

Special rules for medical device classification are the rules 14 to 22.

Special rules address unique situations not easily categorized in the previous groups. These rules cover devices incorporating medicinal products, devices manufactured utilizing tissues or cells, and devices for contraception or prevention of the transmission of sexually transmitted diseases, among other special cases.

The special rules focus on specific risk factors and potential complications associated with devices’ unique features.

Medical devices covered by rules 14 to 22 can be classified as Class IIa, Class IIb, or Class III.

What Is the Difference Between EU MDR and FDA Medical Device Classification?

The EU MDR takes a more detailed approach to medical device classification than the FDA. The FDA focuses on the overall risk of the device without delving into finer details like body placement and duration of use.

According to the FDA medical device classification, medical devices are divided into three categories with increasing harm potential: Class I, Class II, and Class III.

What Are the Different EU MDR Medical Device Regulatory Approval Pathways?

The EU MDR medical device approval pathway is directly linked to the device classification, with stricter controls for higher-risk medical devices.

Class I medical devices, posing the least risk, face fewer regulatory requirements. Manufacturers of Class I medical devices can self-declare compliance with common specifications. On the contrary, Class III medical devices, carrying the highest risk, face the most rigorous requirements, including submitting a comprehensive clinical evaluation.

All medical devices intended for sale or marketing in the EU must bear the CE marking, except those medical devices that are used exclusively for research. The CE marking proves product compliance with the EU MDR.

The regulatory pathway for each device class includes the following.

• Class I: Common Specifications, post-market surveillance (PMS), EU declaration of conformity, and CE marking.
• Class IIa: Common Specifications, PMS, Periodic Safety Update Report (PSUR), EU declaration of conformity, and CE marking.
• Class IIb: Common Specifications, PMS, PSUR, clinical evaluation consultation, EU declaration of conformity, and CE marking.
• Class III: Common Specifications, PMS, PSUR, clinical evaluation consultation, EU declaration of conformity, and CE marking.

Below is a visual overview of the different EU MDR medical device regulatory approval pathways.

EU MDR Class I Medical Device Approval Pathway

The pathway to market for Class I medical devices encompasses compliance with the Common Specifications, post-market surveillance (PMS), EU declaration of conformity, and CE marking.

Common specifications are basic requirements all classes of medical devices must comply with. The common specifications include the following requirements.

• General safety and performance requirements that are set out in MDR Annex I.
• Technical documentation requirements are set out in MDR Annexes II and III.
• Clinical evaluation and post-market clinical follow-up (PMCF) are set out in MDR Annex XIV.
• Clinical investigation requirements are set out in MDR Annex XV.

Class I medical device manufacturers must implement a post-market surveillance (PMS) system. The PMS system must be suited to gather, record, and analyze relevant data on the device’s quality, performance, and safety throughout its lifecycle. From this data, manufacturers identify issues and implement any necessary corrective and preventive actions.

The EU declaration of conformity demonstrates compliance with the requirements. For Class I medical devices, the declaration of conformity can be self-declared without needing an assessment by a notified body.

After Class I medical devices are approved by national authorities, manufacturers can place the CE marking on the medical device and access the EU market.

EU MDR Class IIa Medical Device Approval Pathway

The pathway for Class IIa medical devices within the EU MDR comprehends the Common Specifications, PMS, Periodic Safety Update Report (PSUR), EU declaration of conformity, and CE marking.

Class IIa medical devices are subject to the same common specifications and PMS requirements as Class I medical devices.

However, a notified body must assess compliance with applicable requirements due to Class IIa devices’ higher potential risk of harm. For Class IIa medical devices, the notified body is responsible for issuing the EU declaration of conformity.

Class IIa medical devices are required to provide the Periodic Safety Update Report (PSUR). The PSUR summarizes the results and conclusions of the analyses of the post-market surveillance data gathered. The PSUR must include a rationale and description of any preventive and corrective actions taken in case of issues.

Upon approval of both national authorities and a notified body, Class IIa medical devices can receive the CE marking and access the EU market.

EU MDR Class IIb Medical Device Approval Pathway

The pathway to market for Class IIb medical devices includes compliance with the Common Specifications, PMS, PSUR, clinical evaluation consultation, EU declaration of conformity, and CE marking.

Class IIb medical devices follow the same regulatory pathway as Class IIa medical devices.

On the other hand, Class IIb medical devices pose a moderately higher risk to patients. Thus, the notified body must perform a clinical evaluation consultation during the conformity assessment.

The clinical evaluation consultation analyzes the Class IIb medical device’s clinical data, particularly the device’s benefit-risk profile and compatibility with the intended use.

EU MDR Class III Medical Device Approval Pathway

The regulatory pathway for Class III medical devices faces the most rigorous requirements, including Common Specifications, PMS, PSUR, clinical evaluation consultation, EU declaration of conformity, and CE marking.

Class III medical devices under EU MDR are subject to all requirements applicable to Class I, Class IIa, and Class IIb medical devices, from general safety requirements to clinical evaluation consultations.

After Class III medical devices receive approval from national authorities and notified bodies, manufacturers can affix the CE marking on the device and access the EU market.

What Is the Role of eQMS in Facilitating EU MDR CE Marking Regulatory Process?

Electronic Quality Management System (eQMS) facilitates obtaining CE marking for medical devices under the EU MDR by streamlining quality-related processes, workflows, and documentation required for compliance.

Electronic QMS simplifies the creation, version control, and storage of vital documentation, including technical files, post-market surveillance reports, and clinical evaluations. The eQMS improves accessibility and traceability, facilitating efficient reviews by authorities and notified bodies.

The medical device QMS software supports compliance with several regulatory requirements, including ISO 13485:2016, MDR, IVDR, GMP, 21 CFR Part 11, and 820, among others.

SimplerQMS offers a fully GAMP 5-validated QMS software solution, supporting compliance with EU MDR for medical device quality management systems.

The SimplerQMS solution helps medical device companies comply with regulatory requirements with comprehensive QMS process support. SimplerQMS supports several QMS processes, such as document control, change management, training, risk management, audit management, CAPA management, and more.

Streamline your EU MDR approval process with SimplerQMS. Schedule a personalized demo with one of our Quality Solution Consultants today to discover how the SimplerQMS solution can enhance your quality management processes and accelerate your time to market.

The post EU MDR Medical Device Classification: Classes, Examples appeared first on SimplerQMS.

Examples of FDA Class I medical devices include tongue depressors, manual stethoscopes, and bandages. FDA Class II medical devices contain wheelchairs, contact lenses, and blood glucose meters. FDA Class III medical device examples encompass pacemakers, defibrillators, and artificial hips.

The FDA recommends methods for determining the classification of medical devices: by searching their database using the device’s product code or by comparing new devices to similar, previously approved ones.

Similar to the FDA’s tiered system, the European Union Medical Device Regulation (EU MDR) categorizes devices based on risk, establishing requirements for patient safety and market approval.

Each medical device classification has distinct requirements, from general controls to rigorous premarket approvals.

Quality Management System (QMS) software streamlines the regulatory approval processes for medical devices. An increasing number of companies are adopting QMS solutions for efficient quality management and to ensure compliant processes.

SimplerQMS provides fully validated QMS software, according to GAMP 5, tailored to the needs of medical device companies. To learn more about how our QMS software streamlines quality management processes, schedule a demo with our quality solution specialist.

This article covers the following topics in more detail:

• What Are FDA Medical Device Classes?
• What Is an FDA Class I Medical Device?
• What Is an FDA Class II Medical Device?
• What Is an FDA Class III Medical Device?
• How To Classify Your Medical Device According to FDA Classification Rules?
• What Is the Difference Between FDA and EU MDR Medical Device Classification?
• What Are the Different FDA Medical Device Approval Pathways?
• What Is the Role of QMS Software in Facilitating FDA Medical Device Approval?

What Are FDA Medical Device Classes?

The FDA categorized medical devices into three classes: Class I, Class II, and Class III.

Medical device classes are a tiered categorization scheme based on potential risks to patients.

Class I medical devices present the lowest risk with minimal potential for harm. Class II medical devices are at moderate risk, having a higher risk than class I devices. Class III medical devices present the highest risk, encompassing devices that sustain or support life.

The medical device classification directs the proportionate regulatory controls for safe and effective market availability. The classification system defines progressively stricter controls as the risk level increases.

By thoroughly understanding the FDA’s medical device classification system, medical device manufacturers can streamline their development process, ensure compliance with relevant requirements, and ultimately deliver safe and effective medical devices to market.

What Is an FDA Class I Medical Device?

FDA Class I medical devices encompass the lowest-risk category of devices. Class I medical devices pose minimal potential for harm to users and typically require the least regulatory control compared to higher-class devices.

Out of all the regulated medical devices, 35% are considered to be Class I medical devices, according to the FDA Center for Devices and Radiological Health (CDRH) in 2020.

What Are FDA Class I Medical Device Examples?

Examples of medical devices in Class I are given below.

• Plasters
• Surgical mask
• Manual stethoscopes
• Electric toothbrushes
• Enema kits
• Bedpans
• Tongue depressor
• Oxygen mask
• Hospital beds

What Is an FDA Class II Medical Device?

FDA Class II medical devices comprehend devices deemed to pose a moderate risk to users.

Class II medical devices necessitate additional regulatory controls to mitigate potential risks and ensure their safety and effectiveness when compared to the minimal potential for harm associated with Class I medical devices.

Of all approved devices on the market, 53% are considered Class II medical devices, according to the FDA CDRH in 2020.

What Are FDA Class II Medical Device Examples?

Examples of medical devices in Class II are given below.

• Powered wheelchairs
• Pregnancy test kits
• Surgical gloves
• Catheters
• Blood pressure cuffs
• Blood transfusion kits
• Absorbable sutures
• Syringes
• Contact lenses

What Is an FDA Class III Medical Device?

FDA Class III medical devices encompass devices with the highest potential for harm. Class III devices sustain or support life, are implanted, or present a potentially unreasonable risk of illness or injury.

Class III medical devices face the strictest regulatory requirements compared to their lower-class counterparts due to their potential for significant harm. Class III medical devices demand rigorous premarket approval processes with extensive data on safety and efficacy, whereas Class I and Class II medical devices require general and special controls, respectively.

Of all the approved medical devices, 9% are considered Class III, according to the FDA CDRH in 2020.

What Are FDA Class III Medical Device Examples?

Examples of medical devices in Class III are given below.

• Defibrillators
• Implantable pacemakers
• Implanted prosthetics
• Breast implants
• Cochlear implants
• High-frequency ventilators
• Fetal blood sampling monitors

How To Classify Your Medical Device According to FDA Classification Rules?

There are different methods by which medical device manufacturers can determine the class of their medical devices in the US market.

Key methods endorsed by the FDA for effectively classifying medical devices are listed below.

• Device Classification Panel
• Product Classification Database
• Similar Devices by Clearance or Approval
• Similar Devices by Device Listing

Method 1: Device Classification Panel

The FDA organizes medical device classifications into 16 specialized panels covering diverse medical specialties, such as cardiovascular, immunology, orthopedic, ear, nose, and throat, among others.

The FDA device classification panel encompasses over 1,700 distinct types of medical devices, offering a structured framework for manufacturers to identify applicable classifications and requirements.

Medical devices can be classified by finding the corresponding description of the device in Title 21 of the Code of Federal Regulations (CFR), Parts 862-892.

Manufacturers who know the device panel to which their device belongs can go directly to the listing for that panel and identify the device and the corresponding regulation.

Method 2: Product Classification Database

Medical device manufacturers can search directly for an appropriate product classification in the FDA’s public Product Classification Database.

Manufacturers can search the database using either the specific device product code or a portion of the device’s name.

FDA product codes are three letters used to identify specific medical devices within the FDA’s regulatory framework. Manufacturers who know their device’s product codes can find the device class and applicable requirements directly.

Method 3: Similar Devices by Clearance or Approval

Similar devices already being marketed can be used as a model to determine the classification of new ones.

Medical device manufacturers can work backward by determining how a similar device has been classified based on its clearance or approval to market. Manufacturers can then decide if the same classification applies to the new proposed device.

For this method, manufacturers can search the different databases depending on the device’s marketing authorization route.

• 510(k) Clearance: The 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is safe and effective. The Premarket Notification 510(k) database encompasses most Class II devices requiring 510(k) clearance from the FDA before being legally marketed.
• Premarket Approval (PMA): The PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Manufacturers can find the approved Class III medical devices in the Premarket Approval database.
• De Novo: The De Novo request provides a marketing pathway to classify novel medical devices of low to moderate risk. Innovative Class I and II devices can be found in the De Novo database.

Method 4: Similar Devices by Device Listing

Medical device manufacturers can access a comprehensive listing of all registered medical devices and search for similar devices to be used as a classification model.

Most Class I and some Class II medical devices may not be listed in the clearance or approval databases because they are exempt and do not require the FDA’s review before marketing.

However, device registration and listing are general controls mandated for all medical devices in the US. Thus, the Establishment Registration and Device Listing database provides the list and classification of all currently marketed devices.

What Is the Difference Between FDA and EU MDR Medical Device Classification?

The FDA takes a broader approach to classifying medical devices than the EU MDR.

Both the FDA and EU MDR share a focus on risk-based classification. However, the MDR system employs more classes, offering a more stringent and detailed approach to classifying medical devices.

According to the EU MDR medical device classification, medical devices are categorized into Class I, IIa, IIb, and III. Moreover, MDR subdivides Class I devices in Is, Im, and Ir based on specific sterility, measurability, or reusability characteristics, respectively.

What Are the Different FDA Medical Device Approval Pathways?

The approval pathway for a medical device in the US is directly linked to its classification by the FDA.

The regulatory control level directly correlates with a medical device’s designated risk class. Class I medical devices, representing the lowest potential risk to patients, are subject to the most minimal regulatory controls, such as Good Manufacturing Practices (GMP) and labeling requirements.

On the other hand, Class III medical devices, posing the highest potential risk, require the most stringent regulatory requirements, including premarket approvals and extensive post-market surveillance.

The regulatory controls for each device class include:

• Class I: General Controls and Premarket Notification 510(k)
• Class II: General Controls, Special Controls, and Premarket Notification 510(k)
• Class III: General Controls, Special Controls, and Premarket Approval (PMA)

Below is a visual overview of the medical device FDA approval pathway.

FDA Class I Medical Device Approval Pathway

The pathway to market for Class I medical devices encompasses General Controls and, in some cases, Premarket Notification 510(k).

General controls are basic requirements that every medical device manufacturer must comply with, regardless of class. General controls cover aspects such as good manufacturing practices, quality management systems, labeling, and adverse event reporting.

Many Class I medical devices are exempt from Premarket Notification 501(k) due to their low risk and well-established technology. However, some Class I devices, particularly those that are novel or raise potential safety concerns, may require a 510(k) to demonstrate their substantial equivalence to a similar device already cleared by the FDA.

FDA Class II Medical Device Approval Pathway

The pathway for Class II medical devices within the FDA regulatory framework faces General Controls, Special Controls, and Premarket Notification 510(k).

Class II medical devices must comply with General Controls, similar to Class I devices, and may or may not need to submit a Premarket Notification 510(k) based on their potential risk to user safety. However, due to Class II devices’ moderately higher potential risk, additional Special Controls must be in place.

Special Controls are regulatory requirements for Class II devices for which general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of the device.

Special controls are usually device-specific and include:

• Performance standards
• Post-market surveillance
• Patient registries
• Special labeling requirements
• Premarket data requirements
• Guidelines

FDA Class III Medical Device Approval Pathway

The regulatory pathway for Class III medical devices encounters the most stringent requirements, including General Controls, Special Controls, and Premarket Approval (PMA).

Class III devices are subject to the foundational frameworks of General Controls, just like Class I and II devices, ensuring adherence to good manufacturing practices. If necessary, Class III medical devices must also comply with Special Controls.

The defining requirement for Class III devices is the Premarket Approval (PMA). The PMA approval is based on a determination by the FDA that the device documentation contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use.

Data requirements for PMA include the following.

• Non-clinical Laboratory Studies Section: The non-clinical laboratory studies section comprises data and analyses from microbiology, toxicology, immunology, biocompatibility, stress, wear, and shelf-life studies, along with other relevant testing. The non-clinical laboratory studies section must thoroughly assess the device’s safety and efficacy profile.
• Clinical Investigations Section: The clinical investigations section comprehends the data from the clinical investigations, encompassing study protocols, safety and efficacy outcomes, adverse events, device failures and replacements, patient information and complaints, statistical analyses, and any other pertinent information gathered from the research.

What Is the Role of QMS Software in Facilitating FDA Medical Device Approval?

The Quality Management System (QMS) software facilitates FDA approval by streamlining documentation, risk management, and compliance management processes throughout medical devices’ entire development and approval lifecycle.

QMS software organizes essential documents like design input and output, design verification and validation, design review, procedures, and records, ensuring easy access and audit readiness. Pre-defined workflows and notifications help manage risks and audits, showcasing continuous improvement efforts to the FDA.

The medical device QMS software supports manufacturers in achieving compliance with regulatory requirements, including 21 CFR Part 11 and 820, GMP, ISO 13485:2016, MDR, and IVDR, among others.

SimplerQMS provides QMS software fully validated according to GAMP 5. Our software solution ensures compliance with the software validation requirements of FDA 21 CFR Part 820.70.

The SimplerQMS solution supports companies in achieving compliance with regulatory requirements by providing comprehensive QMS process support. SimplerQMS supports all QMS processes, such as document control, change management, training, supplier management, audit management, nonconformances, and more. The system offers document collection and archive capabilities to structure data and facilitates regulatory submissions.

Facilitate your journey to FDA approval with SimplerQMS. Book a personalized demo with one of our Quality Solution Consultants today and explore how the SimplerQMS solution can optimize your quality management processes and get to market faster.

The post FDA Medical Device Classification: Classes, Examples appeared first on SimplerQMS.

A well-documented technical file indicates that the medical device complies with applicable regulatory requirements, such as the European Medical Device Regulation (MDR).

A compliant medical device technical file is essential for obtaining and maintaining market authorization for the device in the European Union. The medical device technical file is a requirement for approval before placing devices on the market, except for custom-made devices.

This article covers what the medical device technical file is, its importance when it is required, applicable requirements, content, examples, and how it is reviewed. We also discuss the role of QMS software in managing the medical device’s technical documentation.

Medical device companies are increasingly adopting Quality Management System (QMS) software, utilizing this solution to facilitate efficient compilation and management of the medical device technical file.

SimplerQMS provides fully validated eQMS software tailored to the needs of medical device companies. Book a demo with one of our specialists to see how it can streamline your quality management processes.

This article covers the following topics in more detail:

• What Is a Medical Device Technical File?
• Why Is Medical Device Technical Documentation Important?
• When Is a Technical File Required?
• What Are the Requirements for Medical Device Technical Documentation?
• What Is the Content of a Medical Device Technical File?
• What Is the Medical Device Technical File Format?
• What Is an Example of a Medical Device Technical File Structure?
• How Is a Medical Device Technical File Reviewed?
• What Is the Role of QMS Software in Managing Medical Device Technical Documentation?

What Is a Medical Device Technical File?

A medical device technical file is a comprehensive collection of documents that contains all the technical information and data related to a medical device. The medical device technical file includes information on the device, such as design, manufacturing, testing, clinical evaluation, and risk management.

A medical device technical file is used to demonstrate to regulatory authorities that a medical device complies with all applicable regulatory requirements.

Medical device technical file can also be referred to as medical device technical documentation.

The terms technical file and technical documentation are used in European Union (EU) requirements, such as the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

In the United States (US), a similar document is referred to as the Device Master Record (DMR) in regulation FDA 21 CFR Part 820.

In the US, as per FDA 21 CFR Part 820 regulation, all documents related to a medical device are comprised of the Device Master Record (DMR), Device History Record (DHR), and Design History File (DHF).

Despite their different applications in different markets, the DHR, DHF, DMR, and Technical Files or Technical Documentation are all essential documents for medical device regulatory compliance and to demonstrate the device’s safety and effectiveness.

Why Is Medical Device Technical Documentation Important?

Medical device technical documentation is important because it helps demonstrate that the medical device is safe and effective for its intended use.

By meticulously documenting every aspect of a medical device, manufacturers can demonstrate to regulatory authorities that the device meets all necessary safety and performance requirements.

Furthermore, technical documentation is a requirement for conformity assessments and approval processes.

A notified body must approve medical devices before they can be marketed and sold in the European Economic Area (EEA) unless they are for research purposes or Class I non-sterile, non-reusable surgical instruments, and without measuring function devices. The approval process requires the submission of a medical device technical file.

In case a medical device malfunctions or causes harm, the technical documentation also helps find and fix the problems, protecting public health and keeping the manufacturer’s reputation intact.

Compiling the vast amount of technical documentation needed for a medical device technical file is a complex and challenging process.

SimplerQMS simplifies managing and organizing the extensive technical documentation required for medical devices, including product design and development records, clinical evaluation reports, risk management files, biocompatibility studies, validation and verification reports, and more.

When Is a Technical File Required?

A medical device technical file is required for medical devices that are marketed and sold in the European Economic Area (EEA).

Before a medical device can be legally sold, its technical file must be prepared and submitted as part of the conformity assessment process. The file is essential for demonstrating compliance with relevant regulatory requirements, such as the European Medical Device Regulation (MDR).

Any substantial changes to the medical device, its intended use, or its manufacturing process may require updating and resubmitting the technical file.

However, the requirement for a technical file may vary depending on the EU classification of medical devices.

Devices in Class I that are non-sterile, non-reusable surgical instruments and without measuring functions are not required to present the technical file to notified bodies. Due to their low risk, these devices can issue a self-declaration of conformity with EU regulations.

Still, some manufacturers choose to maintain a medical device technical file, as it helps add value, reduce risk, and demonstrate compliance.

What Are the Requirements for Medical Device Technical Documentation?

Requirements applicable to medical device technical documentation are the following:

• Medical Device Regulation (MDR)
• In Vitro Diagnostic Regulation (IVDR)
• ISO 13485:2016

Medical Device Regulation (MDR)

The Regulation 2017/745, also known as the Medical Device Regulation (MDR), is the current regulation governing medical devices in the European Union. The MDR came into effect in May 2021 and replaced the Medical Device Directive (MDD).

The MDR specifies the requirements for medical device technical documentation in Annex II and Annex III.

Annex II outlines a comprehensive list of all the information manufacturers must include in their technical documentation to demonstrate that their devices are safe and effective.

Some of the MDR Annex II technical documentation elements include:

• Device description and specification, including variants and accessories
• The basic unique device identifier (UDI) code
• Principles of operation of the device and its mode of action
• Detailed information regarding test design, study protocols, and methods of data analysis
• Label and packaging information
• Instructions for use in the languages where the device is going to be sold
• Design and manufacturing information
• Identification of all sites, including suppliers and sub-contractors
• General safety and performance information
• Benefit-risk analysis and risk management
• The risk class of the device and the justification for the classification rule
• Product verification and validation
• Software verification and validation
• The clinical evaluation plan and clinical evaluation report

Annex III specifies the requirements for technical documentation on post-market surveillance.

The manufacturer must have a proactive and systematic approach to collecting information for developing comprehensive technical documentation in the form of a post-market surveillance plan.

The post-market surveillance plan must address the collection and utilization of information concerning non-serious incidents, serious incidents, and undesirable side effects. It includes feedback and complaints provided by users, information from trend reporting, and relevant specialist or technical literature.

To ensure compliance with EU MDR, manufacturers must implement an MDR-compliant Quality Management System (QMS) that meets the specific requirements outlined in the regulation.

In Vitro Diagnostic Regulation (IVDR)

The Regulation 2017/746, better known as In Vitro Diagnostic Regulation (IVDR), currently governs the commercialization of medical devices for in vitro diagnostics in the European Union.

The EU IVDR came into effect in May 2022 and replaced the In Vitro Diagnostic Directive (IVDD). The IVDR is a more comprehensive and stringent regulation designed to improve the safety and performance of in vitro devices placed on the EU market.

The IVDR Annex II and Annex III specify the requirements for devices’ technical documentation.

Similar to MDR, Annex II provides a list of all information to be included in the technical documentation.

Examples of the IVDR Annex II elements that constitute the technical documentation include:

• The product’s name, a general description of its function, and intended users
• The unique device identifier (UDI) code
• The intended patient population and medical conditions to be diagnosed, treated, or monitored
• The device label and packaging in the languages where the device is going to be sold
• The rationale for classifying the product as a medical device
• Information to allow the design stages applied to the device to be understood
• Description of the accessories for a device
• The device’s risk class and the justification for that classification
• The general safety and performance requirements that apply to the device
• The benefit-risk analysis
• Details of any software used with the device

Annex III also outlines the requirements for technical documentation on post-market surveillance.

The manufacturer must have a post-market surveillance system integral to the quality management system.

The data gathered by the post-market surveillance system should be used to update the benefit-risk determination, clinical evaluation, safety and clinical performance, and design and manufacturing information.

ISO 13485:2016

The ISO 13485:2016 is the international regulatory standard that establishes the requirements for the medical device quality management system.

In Section 4.2.3, regarding the medical device file, the standard requires each medical device to have a technical file demonstrating compliance with all the applicable regulatory requirements.

The medical device file must include, but is not limited to, the following information:

• A general description of the medical device, its intended use and purpose, labeling, and instructions for use.
• Specifications for the product.
• Specifications or procedures for manufacturing, packaging, storage, handling, and distribution.
• Procedures for measuring and monitoring the quality of the medical device.
• Requirements for installation and servicing (as applicable).

To meet the technical file requirement and all other ISO 13485:2016 requirements, medical device manufacturers must adopt an ISO 13485:2016 compliant QMS. Such a QMS facilitates the comprehensive management and control of the entire lifecycle of medical devices, encompassing design, development, production, and even post-market activities.

What Is the Content of a Medical Device Technical File?

The technical file for a medical device must contain at least the following sections based on the EU MDR.

• Device description and specification
• Labeling and instructions for use
• Design and manufacturing information
• General safety and performance
• Risk management documentation
• Verification and validation information
• Post-market surveillance (PMS) information

Device Description and Specification

The device description and specification in the technical file serve as a comprehensive overview of the device. This overview provides detailed information about the device’s design, components, intended use, and performance characteristics.

Below are examples of technical documents that must be included:

• Engineering drawings and schematics
• Material specifications
• Manufacturing process descriptions
• Functional test plans and results
• Risk management documentation

The technical file must also include a Unique Device Identification (UDI) number for each medical device.

A Unique Device Identification (UDI) number is a globally recognized code that uniquely identifies a medical device. It consists of a numeric or alphanumeric code that identifies the device, expiration date, lot number, and serial number.

Labeling and Instructions for Use

The labeling and instructions for use section of the medical device technical file provides comprehensive guidance on the safe and effective use of the device.

These documents serve as a communication tool between the manufacturer and the device users, ensuring that users have the necessary information to operate the device correctly and minimize the risk of adverse events.

Labeling and instructions for use documents include:

• Label artwork
• Translated instructions for use
• User training materials
• Video demonstrations

The complete set of device labels and instructions for use should be included in all the official languages of the target markets.

Design and Manufacturing Information

The design and manufacturing information section of the medical device technical file provides detailed insights into the device’s design and production processes. This section includes information on the materials used, the manufacturing processes, and the quality control procedures in place.

This information is essential for demonstrating that the device is manufactured consistently and meets all applicable safety and quality standards.

Some examples of design and manufacturing documents are:

• Engineering drawings and schematics
• Material specifications
• Manufacturing process flowcharts
• Quality control plan and records
• Batch records

General Safety and Performance

The general safety and performance information in the medical device technical file demonstrates that the device complies with all applicable safety and performance requirements. It provides evidence that the device is designed, manufactured, and tested to ensure patient safety, efficacy, and reliability.

Examples of general safety and performance information include:

• Risk management documentation
• Clinical evaluation reports
• Performance testing reports
• Biological evaluation reports
• Electrical safety reports
• Mechanical safety reports

These documents include a justification, validation, and verification of the solutions adopted to meet general safety and performance.

Risk Management Documentation

Risk management documentation is an essential component of the technical file for medical devices. It showcases the systematic approach to identifying, assessing, and mitigating potential hazards associated with the device’s use.

Some examples of risk management documentation are the following:

• Hazard identification and risk assessment reports
• Risk management plan
• Residual risk evaluation report
• Benefit-risk analysis report
• Risk acceptance statement

Verification and Validation Information

The verification and validation information provides comprehensive documentation demonstrating the device’s conformity with the requirements. The documentation proves that the device meets the general safety and performance requirements.

Below are examples of verification and validation documents:

• Verification plans and test results
• Validation plans, test protocols, and test results
• Traceability matrices
• Risk mitigation traceability reports
• Change management documentation

Post-Market Surveillance (PMS) Information

Post-market surveillance (PMS) is a critical component of medical device lifecycle management, ensuring that devices continue to meet safety and performance expectations throughout their lifespan.

The PMS information section of the technical file outlines the manufacturer’s plan for monitoring the device’s safety and performance after it has been placed on the market.

Examples of PMS documentation might include:

• PMS plan overview
• Data collection procedures
• Data analysis and evaluation plan
• Risk assessment and mitigation procedures
• Regulatory reporting procedures

To ensure medical device technical documentation is comprehensive, companies usually follow the Summary of Technical Documentation (STED) format.

What Is the Medical Device Technical File Format?

A medical device STED is a document that compiles the information in a medical device technical file. It was created by the Global Harmonization Task Force (GHTF), the precursor to the current International Medical Device Regulators Forum (IMDRF), to standardize medical device regulatory submissions across markets globally, assisting both manufacturers and regulatory authorities.

The STED is intended to provide a high-level overview of the device, its design, manufacturing, and quality control processes, and the evidence supporting its safety and performance.

The information provided may include, for example, abstracts, high-level summaries, or existing controlled documents, as appropriate, sufficient to communicate key relevant information and allow a reviewer to understand the subject and assess the validity of that information.

The use of the STED should reduce costs for the manufacturer and reviewer, remove trade barriers, and facilitate timely international access to medical devices. 

Additionally, the IMDRF Table of Content (IMDRF ToC) is another document that provides specific guidelines for the acceptable folder structure and file formats for regulatory submissions. For example, folder naming convention, file and submission size limitations, document security, hyperlinking in PDF files, pagination, and more.

What Is an Example of a Medical Device Technical File Structure?

Below is an example of a medical device technical file folder structure in the SimplerQMS solution.

The SimplerQMS system provides a well-organized and easy-to-use platform for managing medical device technical documentation. You can create dedicated sections for device description, labeling, risk management, post-market surveillance, and more.

Note that the same documents in the SimplerQMS software can be linked to multiple archives, such as medical device technical files, DMRs, DHFs, and DHRs.

For example, a company entering the US market needs to submit various documents to comply with local regulations.

Instead of maintaining multiple copies of these documents in separate folders for each regulatory submission, the company can utilize a single electronic document that is linked to multiple archives.

When the document is updated, it is automatically reflected in all the linked archives, eliminating the need to update a document in each folder.

You can easily create a snapshot of each product’s current technical documentation and share it with the appropriate regulatory authorities.

Our software facilitates finding the information you need and helps ensure that your technical file is complete and compliant with all applicable regulations.

How Is a Medical Device Technical File Reviewed?

The review of a medical device technical file is a process where a regulatory authority or a notified body examines the technical documentation of a medical device. This examination aims to determine whether the device meets all applicable regulatory requirements.

The medical device technical file review is typically conducted during the medical device audit.

The audit is conducted in two stages. Stage 1 involves assessing the completeness and organization of the company’s documentation, including the technical file, usually remotely. At stage 2, the auditor evaluates the company’s processes, which take place on-site.

A QMS software platform helps medical device companies manage their technical documentation. SimplerQMS provides eQMS with a document collection tool that allows manufacturers to easily collect, organize, and store all the documents required for their technical files.

What Is the Role of QMS Software in Managing Medical Device Technical Documentation?

The role of QMS software is to streamline technical documentation management.

QMS software automates workflows for creating, reviewing, and approving technical documentation, tracks and manages versions, manages changes, and generates audit trails.

These capabilities allow medical device companies to improve the efficiency and effectiveness of their technical documentation management process, helping reduce the risk of compliance issues and improving the quality of products.

SimplerQMS provides fully validated eQMS for medical device companies to streamline quality management processes and quality documentation management, including the management of technical documentation.

Our system provides predefined workflows for tasks such as document creation, review, and approval, streamlining technical documentation management.

All technical documentation is stored in a single repository, making it easy to find and access documents when needed.

SimplerQMS system also supports compliance with the medical device industry requirements, including ISO 13485:2016, FDA 21 CFR Part 11 and 820, EU GMP Annex 11, EU MDR and IVDR, and more.

We provide comprehensive support for QMS processes, such as document control, design control, risk management, change control, training management, nonconformance management, CAPA management, customer complaint management, audit management, supplier management, and more.

Assess the benefits of investing in an eQMS solution for your company by downloading our free eQMS Business Case template.

The template will help you understand SimplerQMS’s specific benefits for your business, such as potential efficiency gains, cost savings, and compliance improvements. By presenting this information to management, you can build a strong case for implementing an eQMS.

Final Thoughts

A medical device technical file, or technical documentation, is a comprehensive document collection that contains all the technical information and data related to a medical device.

Medical device technical files demonstrate to regulatory authorities that a medical device complies with all applicable regulatory requirements.

Medical device companies are implementing quality management system (QMS) software to streamline quality management processes and manage medical device technical files and other essential documentation.

SimplerQMS is a fully validated (GAMP 5) eQMS software solution for medical device companies that streamlines quality management, including the management of technical documentation.

The system streamlines the process of creating, reviewing, and approving technical documents through predefined workflows. Document changes are automatically tracked, and new versions of the documents are recorded in time-stamped audit trails.

Experience how SimplerQMS can streamline your quality management processes and help you manage your technical documentation more efficiently by booking a demo with our Quality Solution Experts.

The post Medical Device Technical File (Technical Documentation) appeared first on SimplerQMS.

The medical device complaint handling process is a mandatory requirement for medical device manufacturers under various regulatory frameworks, including ISO 13485:2016, 21 CFR Part 820, and the European Medical Device Regulation (MDR).

All these regulatory frameworks emphasize the importance of establishing and maintaining a robust complaint handling system to ensure patient safety, product quality, and regulatory compliance.

This article discusses the entire medical device complaint handling process, including what complaints are, complaint types and examples, and the requirements of the complaint handling process. It also explains the role of the medical device complaint handling software solution.

The complexities of medical device complaint handling highlight the need for QMS software, which provides a centralized and efficient solution to streamline and improve the customer complaint process.

SimplerQMS provides fully validated eQMS software tailored to the unique needs of medical device companies. You can book a free demo and talk to our specialists to see how our software can improve your quality management processes, including the handling of medical device complaints.

This article covers the following topics:

• What Is a Complaint?
• What Are Medical Device Complaint Examples?
• What Are the Different Types of Medical Device Complaints?
• What Are the Requirements for Device Complaint Handling?
• What Is the Medical Device Complaint Handling Process?
• What Are the Benefits of a Well-Designed Complaint Handling Process?
• What Is the Role of Medical Device Complaint Handling Software?

What Is a Complaint?

A complaint is an expression of dissatisfaction made by a customer or client regarding a product, service, or process, typically due to a perceived failure to meet their expectations or a problem encountered.

Below is the definition of complaint according to some requirements that outline complaint handling processes.

• ISO 13485:2016: Complaints are any written, electronic, or oral communication that claims deficiencies related to the identity, quality, durability, reliability, usability, safety, or performance of a medical device or related to a service that affects the performance of such medical devices.
• FDA 21 CFR Part 820: Complaint means any written, electronic, or oral communication that declares deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

What Is the Difference Between Complaints and Feedback?

The main difference between complaints and feedback lies in their nature and intent.

Complaints are specific expressions of dissatisfaction about a product, service, or experience, often expecting a resolution or response. An example of a complaint is a phone call about a product that is not functioning according to the specifications.

Feedback, on the other hand, is more general and can be positive or negative. Feedback offers insights or opinions to help improve a product, service, or process without necessarily seeking direct resolution of a specific issue. An example of feedback can be an email to demonstrate appreciation for a new product in the market when compared to similar existing products or a survey response detailing negative aspects of a service that could be enhanced.

What Are the Sources of Complaints?

The sources of complaints include multiple communication channels that a company utilizes to interact with its customers.

Below are examples of sources of customer complaints.

• Emails: Complaints received through customer service or company email addresses.
• Phone Calls: Issues reported via call centers or customer support lines.
• Social Media: Complaints are made on social media platforms like LinkedIn, Facebook, Instagram, and others.
• Live Chat: Issues communicated through website live chat.
• Feedback Forms: Complaints are submitted through online or physical feedback forms.
• Text Messages/SMS: Customer grievances are sent via text messaging service or SMS (Short Message Service).
• Company Website: Complaints are submitted through contact forms or portals on the website.
• Direct Mail: Written complaints sent through postal mail.
• Online Review Platforms: Negative reviews or complaints are posted on review platforms like G2 Crowd, Trustpilot, Capterra, Google Reviews, and others.
• In-Person: Direct complaints made at the company’s physical locations.

What Are Medical Device Complaint Examples?

Realistic medical device complaint examples are given below.

• Device Malfunction: A pacemaker is not working as intended, leading to health concerns.
• Software Issues: Glitches in the software of a diagnostic imaging device cause inaccurate results.
• Product Durability: A prosthetic limb breaking or wearing out prematurely.
• Adverse Reactions: Patients experiencing unexpected side effects from using a medical device, like skin irritation from an adhesive in a wearable monitor.
• Inaccuracy: A blood glucose meter provides inaccurate readings.
• Usability Issues: Difficulty in operating a portable dialysis machine due to complex controls.
• Sterility Concerns: Reports of a surgical instrument pack not being properly sterilized.
• Battery Life Problems: Short battery life in a portable oxygen concentrator.
• Incorrect Labeling: A medical device with labels that have incorrect or incomplete usage instructions.
• Delivery Delays: Late delivery of critical medical devices like ventilators to healthcare facilities.

What Are the Different Types of Medical Device Complaints?

Medical device complaints can be grouped into two types: incident-driven and review-driven.

Incident-Driven Complaints

Incident-driven complaints arise due to specific incidents related to the use or performance of the medical device. These complaints demand immediate attention from the company.

Examples of incident-driven complaints are listed below.

• Device malfunctions: The device delivered the wrong medication or dosage, causing the patient to suffer adverse effects.
• Adverse reactions: A patient complains that they developed a rash after using a new device.
• Equipment failures: Defibrillators with electrical problems that could prevent them from delivering a shock.
• Issues leading to inaccurate results or patient harm: A laboratory technician reports that a blood glucose meter is giving inaccurate readings, which could lead to patients receiving incorrect treatment.

Review-Driven Complaints

Review-driven complaints are identified by gathering and analyzing any reported issues regarding the medical device. Review-driven complaints represent past issues and are reviewed periodically.

These complaints include information from various sources, such as incident reports, trend reports, technical literature, distributors’ and importers’ feedback, and customer online reviews.

Review-driven complaints are a valuable source of information for post-market surveillance (PMS), as they provide real-world evidence of how medical devices are being used and how they are performing in clinical practice.

Examples of review-driven complaints are listed below.

• Device malfunctions: Multiple reviews on a retailer’s website mention that a particular blood pressure monitor consistently provides inaccurate readings.
• Device durability: A customer on an online forum complains that a particular medical device broke after a short period of use.
• Software issues: Multiple reviews on an app store complain that a particular software application frequently crashes or freezes, disrupting their workflow or causing data loss.
• Equipment failures: A routine maintenance report reveals that an X-ray machine is not producing clear images.

What Are the Requirements for Device Complaint Handling?

The requirements for device complaint handling include regulations and standards, such as US FDA 21 CFR Part 820, EU MDR and IVDR, and ISO 13485:2016, among others.

ISO 13485:2016

The ISO 13485:2016 is an international standard for quality management systems in the medical device industry.

The standard Section 8.2.2 states that medical device companies must establish and document procedures for handling complaints promptly and in compliance with all relevant regulatory requirements.

These procedures must outline the minimum requirements and responsibilities for:

• Receiving and documenting complaints.
• Assessing whether feedback qualifies as a complaint.
• Investigating complaints thoroughly.
• Determining if regulatory authorities should be notified.
• Managing complaint-related products.
• Deciding whether corrective actions are necessary.

Any corrective action resulting from the complaint handling process should be documented.

The medical device complaint handling process requires appropriate procedures and controls, but other processes are equally crucial for establishing an ISO 13485:2016 compliant Quality Management System (QMS), as detailed in our dedicated guide.

21 CFR Part 820

The 21 CFR Part 820 is a regulation issued by the United States Food and Drug Administration (FDA) that establishes the quality system regulation and the Current Good Manufacturing Practice (cGMP) for medical device manufacturers.

In Section 21 CFR 820.198, the regulation specifies that manufacturers must maintain complaint files and establish procedures for receiving, reviewing, and evaluating complaints through a designated unit.

These procedures must ensure that all complaints are processed in a consistent and timely manner.

A comprehensive record of the complaint investigation should include the following:

• The name of the medical device involved
• The date the complaint was received
• Any unique device identifier (UDI) or universal product code (UPC), along with any other relevant device identification codes or control numbers
• The name, address, and phone number of the individual who filed the complaint
• A detailed description of the nature and specifics of the complaint
• The dates and outcomes of the investigation
• Any corrective actions taken in response to the complaint
• A copy of the response provided to the complainant

In instances where no investigation is conducted, the company must maintain a documented record specifying the rationale and responsible person behind the decision.

Complaints are evaluated to determine whether they represent an event that is required to be reported to the FDA under the regulation 21 CFR Part 803, Medical Device Reporting.

To delve into a comprehensive overview of all the requirements outlined in 21 CFR Part 820 quality system regulation, refer to our dedicated article.

21 CFR Part 803

The FDA 21 CFR Part 803 is a regulation that establishes requirements for medical device reporting. Complaints need to be reported to the FDA under 21 CFR Part 803 when they are related to events of deaths and serious injuries.

The purpose of the regulation is to ensure that the FDA is aware of any serious injuries or deaths associated with medical devices.

The regulation Section 21 CFR 803.18(d) states that device companies must implement and maintain procedures for recording device complaints.

To ensure comprehensive and informative reporting, below are some examples of information that must be included in the medical device reporting:

• Patient information: name or identifier, age at the time of event, date of birth, gender, and weight.
• Patient medical history: pre-existing medical conditions, allergies, and current medications.
• Detailed event description: provide a comprehensive description of the adverse event or product problem.
• Outcomes attributed to the event: consequences associated with the adverse event, such as death, serious injury, or other health complications.
• Relevant tests and laboratory data: dates and results of relevant clinical tests or laboratory data conducted in relation to the event.
• Device information: device name, model number, and device lot number or serial number.
• Manufacturer information: name, address, and contact person.

MDR and IVDR

The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are two regulations in the European Union that outline regulatory requirements for medical devices and in vitro diagnostic medical devices, respectively.

These regulations aim to ensure that devices meet the requirements of safety, performance, and quality.

According to Article 87, manufacturers must submit vigilance reports. Vigilance reporting is the process of collecting, evaluating, and reporting incidents and field safety corrective actions related to medical devices.

All medical device incidents that result in death, serious injury, or an unexpected deterioration in a patient’s health must be reported to the relevant authorities.

In the MDR and IVDR Annex III, feedback and complaints are integral parts of the post-market surveillance plan.

Post-market surveillance (PMS) is the process of monitoring the safety and performance of medical devices after they have been placed on the market to identify and address any potential safety issues.

The post-market surveillance plan must specify the effective and appropriate methods and tools for investigating complaints.

The following are examples of PMS data that should be collected and addressed according to MDR and IVDR.

• Information concerning serious incidents.
• Information from field safety corrective actions.
• Records of non-serious incidents.
• Data on any undesirable side effects.
• Information from trend reporting.
• Information from relevant specialist or technical literature, databases, and registers related to the medical device.
• All information is provided by users, distributors, and importers in the form of complaints and feedback.
• Publicly available information about similar medical devices.
• Information from periodic safety update reports (PSURs).

What Is the Medical Device Complaint Handling Process?

The medical device complaint handling process is a systematic approach to receiving, evaluating, investigating, and responding to complaints regarding medical device products.

The steps involved in the medical device complaint handling process are listed below.

1. Receiving the customer complaint
2. Registering the complaint
3. Reporting medical device complaints (if applicable)
4. Investigating the complaint
5. Closing the complaint

The steps outlined in the medical device compliant handling flowchart provide a general framework for the complaint handling process.

The following sections provide a more detailed explanation of each step, accompanied by examples of how SimplerQMS streamlines the complaint handling process.

1. Receive the Customer Complaint

The complaint-handling process begins with receiving and acknowledging the customer’s complaint.

Companies should provide customers with multiple communication channels to submit complaints, such as phone, email, in-person, and others.

All employees in the company can receive complaints and should be aware of the procedure to forward them to the appropriate person or team. Complaints can be forwarded to supervisors, managers, or a specific department responsible for addressing customer complaints.

It is important to accurately document the customer’s complaint. The complaint form document must include the customer’s name, contact information, a description of the issue, and any relevant details as references for further investigation and resolution.

2. Register the Complaint

Registering a medical device complaint involves creating a formal record of the complaint and assigning it a unique number in the system, such as a customer complaint form.

The complaint record should capture details about the issue, including the date and time of the complaint, complaint description, contact information, initial investigation, and more.

All complaints must be recorded promptly within the specified timeframe, for example, 24 hours after receipt during business hours.

SimplerQMS software provides customizable forms and templates to facilitate the creation of customer complaint forms, ensuring that all relevant information is captured and organized.

Our system provides a centralized repository for customer complaints and related documents, ensuring that all relevant information is readily accessible to authorized personnel.

3. Reporting Medical Device Complaints (If Applicable)

According to 21 CFR Part 803 and EU MDR and IVDR, for complaints that raise potential safety concerns, such as deaths and serious injuries, a medical device vigilance report must be prepared and submitted to the regulatory authorities.

SimplerQMS allows you to specify whether the complaints are reportable or non-reportable.

4. Investigate the Complaint

A thorough investigation of the complaint should be performed to determine the root cause of the issue.

The investigative stage includes collecting all relevant information related to the complaint, including device documentation, patient information, and complaint details.

Once the relevant information is assembled, the next step involves a meticulous analysis of the gathered data to determine the severity and risks of the incident.

Quality assurance personnel then determine whether corrective and preventive actions (CAPA) are necessary to address the issue and prevent future occurrences. These actions may include design modifications, changes to the manufacturing process, or training updates.

SimplerQMS offers automatic reminders and notifications to ensure that all tasks related to the investigation are completed on time, such as reviewing the complaint details, reviewing previous complaints, examining the affected device, performing device testing, and more.

Complaints can be escalated directly to the CAPA process with all documents linked, ensuring traceability and maintaining a comprehensive record of the investigation and resolution process.

5. Close the Complaint

The complaint is formally closed once the complaint handling process is complete and any necessary corrective and preventive actions have been implemented.

Closing a complaint involves documenting its final status with a concise summary of the resolution process. The findings of the investigation and the actions taken to address the issue and prevent the problem from recurring must also be described.

For regulatory purposes, all relevant records must be properly documented. 

SimplerQMS provides a time-stamped audit trail that automatically records every step of the complaint-handling process.

The system records all actions in documents, from initial filing to closure, providing a transparent and traceable history of the complaint.

What Are the Benefits of a Well-Designed Complaint Handling Process?

A well-designed complaint handling process offers numerous benefits for the company and customers.

Some benefits of having a well-designed complaint process are the following.

Regulatory Compliance

A well-designed medical device complaint handling process can help companies stay compliant and avoid noncompliance with requirements such as ISO 13485:2016, MDR, and 21 CFR Part 803 and 820.

According to the official Food and Drug Administration (FDA) Data Dashboard, 368 inspection citations were issued between November 2022 and November 2023 related to the 21 CFR Part 820.198 section regarding complaint files.

Regulatory issues involving 21 CFR Part 820.198 are listed below.

• Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established (240 recurrences).
• Complaints involving the possible failure of a device to meet any of its specifications were not investigated where necessary (40 recurrences).
• Complaint files are not adequately maintained (33 recurrences).
• Records for complaints where no investigation was made do not include the required information (31 recurrences).
• Not all complaints have been reviewed and evaluated to determine whether an investigation is necessary (12 recurrences).
• Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated by a designated individual (11 recurrences).
• Investigation records of MDR reportable complaints do not include the required information (1 recurrence).

Improved Product Quality

A well-designed complaint handling process can help companies identify issues and prevent similar ones from happening again. These actions lead to improved product quality and safety.

Increased Customer Satisfaction

By promptly and effectively addressing customer complaints, companies can demonstrate their commitment to customer satisfaction.

Customers appreciate it when their complaints or feedback are listened to and corrected or implemented, improving customer loyalty.

When customers know that their complaints will be taken seriously and addressed promptly, they are more likely to feel confident in the company and continue doing business with them, building a stronger brand reputation.

Reduced Costs

Companies can reduce costs associated with customer dissatisfaction and prevent future complaints by analyzing customer complaints and addressing identified gaps in their services or products.

Early detection and correction of product issues can avoid the necessity for costly product recalls, which cause substantial expenses related to product withdrawal, customer notification, and replacement provision.

A well-designed complaint handling process can improve product quality, customer satisfaction, and regulatory compliance. It also makes it easier to use specialized software to streamline complaint management.

What Is the Role of Medical Device Complaint Handling Software?

The role of medical device complaint handling software is to streamline the complaint handling process, offering an efficient and systematic approach to managing and resolving complaints.

Modern eQMS solutions have integrated complaint handling capabilities that provide a centralized platform for managing complaints facilitating collaboration among team members. Additionally, the capability to relate documents for traceability allows users to easily track the history of a complaint.

SimplerQMS is a fully validated eQMS software solution for medical device companies with built-in Complaint Management capabilities.

Our solution streamlines the complaint handling process by automating tasks, providing workflows and centralized access to information, and facilitating collaboration among departments.

The software helps medical device companies comply with a variety of requirements, including ISO 13485:2016, MDR and IVDR, FDA 21 CFR Part 803 and 820, and more.

The SimplerQMS solution supports companies in achieving compliance with regulatory requirements by providing comprehensive QMS process support.

Besides complaint management, SimplerQMS provides support for several other QMS processes, such as document control, change control, training management, design control, nonconformance management, CAPA management, audit management, supplier management, and more.

To assess how an investment in an eQMS solution could benefit your company, download our eQMS Business Case template today.

You can build a stronger argument for implementing an eQMS using our template. Clearly explain to management the practical benefits of SimplerQMS, such as improved efficiency, cost savings, and enhanced compliance efforts.

Final Thoughts

The medical device complaint handling process is a systematic approach employed by companies to efficiently manage and resolve complaints. This process encompasses receiving, reviewing, evaluating, investigating, and addressing customer complaints in a timely and effective manner.

The complex nature of medical device complaint handling processes emphasizes the use of Quality Management System (QMS) software. The software streamlines the customer complaint process.

Modern eQMS solutions combine complaint management features with a centralized platform for easy document management, allowing users to track complaint history and gather data seamlessly.

SimplerQMS is a fully validated eQMS software solution tailored for medical device companies with integrated complaint management capabilities.

If you are interested in learning more about how SimplerQMS can help you streamline complaint handling and other quality management processes, we recommend you book a personalized demo today and talk to our Quality Solution Consultants.

The post Medical Device Complaint Handling Process appeared first on SimplerQMS.

Quality system software validation is a requirement when the software is used to manage regulated processes in Life Science industries, which include pharmaceutical, biotechnology, and medical devices, among others.

This article will discuss the definition of QMS software validation, when and why electronic QMS (eQMS) validation is important, relevant requirements, validation methods, benefits, and the role of fully validated eQMS software in helping ensure quality and compliance.

Companies have been increasingly adopting eQMS (Electronic Quality Management System) solutions to streamline their quality processes and improve their compliance efforts.

SimplerQMS provides fully validated QMS software designed specifically for Life Science companies. Book a demo and talk to our quality experts to get a deeper understanding of our eQMS solution.

We will discuss the following topics in more detail:

• What Is QMS Software Validation?
• Why QMS Software Validation Is Important?
• When Electronic QMS Validation Is Necessary?
• Which Requirements Specify eQMS Validation?
• How Is the QMS Software Validated?
• What Are the Benefits of QMS Software Validation?
• What Is the Role of Fully Validated eQMS Software?

What Is QMS Software Validation?

QMS (Quality Management System) software validation is the process of systematically verifying and documenting that QMS software meets predefined requirements, operates effectively, and complies with regulatory standards. QMS software validation falls under the broader category of Computer Systems Validation (CSV), which ensures the integrity and compliance of computerized systems.

QMS software validation involves creating and executing protocols, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

SimplerQMS provides a fully validated eQMS according to ISPE GAMP 5 and performs continuous revalidation. This means that our customers do not need to validate computer software themselves and can be confident that their eQMS is compliant and ready to use right away.

Why QMS Software Validation Is Important?

QMS software validation is important to demonstrate that the eQMS software performance is accurate and consistent. This ensures the integrity and quality of documentation and processes managed within the system.

Companies using software for managing QMS must comply with applicable FDA and ISO requirements concerning system validation.

When Electronic QMS Validation Is Necessary?

QMS software validation is necessary when it is required as per applicable regulatory requirements, specifically when computer software is used to control the quality management system.

QMS software must be validated before use and revalidated as necessary to follow any changes, according to ISO 13485:2016 Section 4.1.6 and FDA 21 CFR 820.70. Both requirements mandate these validation activities and their results to be documented.

Which Requirements Specify eQMS Validation?

QMS software validation is a requirement in several regulations, standards, and guidelines in the Life Science industry.

Below are some requirements that require eQMS validation.

FDA 21 CFR Part 11

The Food and Drug Administration (FDA) regulation 21 CFR Part 11 sets forth the criteria for electronic records, signatures, and computer systems to be trustworthy and reliable.

Regarding QMS software validation, section 21 CFR 11.10(a) specifies that systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

To learn more about this and other requirements in 21 CFR Part 11, read our dedicated article.

EU GMP Annex 11

The EU GMP Annex 11 provides the Good Manufacturing Practices (GMP) on the use of computerized systems in the Life Sciences industries in the European Union.

Section 4 provides general principles for validating computerized systems used in manufacturing pharmaceutical products. This section specifies the requirements for validation documentation, test methods, system inventory, and more.

Check out our article on Annex 11 for a deeper explanation of what this guideline entails.             

ISO 13485:2016

The international standard ISO 13485:2016 specifies the requirements for a quality management system for medical device companies.

It is established in Section 4.1.6 that the application of computer software used in the quality management system must be validated before use and after changes. The validation activities need to be equivalent to the risk associated with the use of the software.

If you are interested in knowing more about what an ISO 13458:2016 compliant QMS encompasses, read our article.

FDA 21 CFR Part 820

The FDA 21 CFR Part 820, also known as quality system regulation, sets forth the cGMP requirements for medical devices. These requirements are intended to ensure that the devices are safe and effective.

Section 21 CFR 820.70(i) states that manufacturers must validate computer or automated data processing systems when used as part of production or the quality system for its intended use.

All software changes must be validated before approval and implementation, and these validation activities and results need to be documented.

Read our article to learn more about 21 CFR Part 820 purpose and requirements.

GMP Guide Part II APIs

The GMP Guide Part II APIs is a set of international guidelines that provide guidance on GMP for the manufacturing of active pharmaceutical ingredients (APIs) in a way that meets the required quality and purity requirements.

In Section 12, it is defined that the company’s approach to validation, including the validation of computerized systems, should be documented. Systems should be periodically evaluated to verify that they are still operating in a valid manner.

How Is the QMS Software Validated?

QMS software validation is conducted through a structured process involving specific steps.

QMS software validation steps are listed below.

1. Risk Management
2. Validation Planning
3. Installation Qualification (IQ)
4. Operational Qualification (OQ)
5. Performance Qualification (PQ)
6. Validation Reporting, including the Validation Certificate

1. Risk Management

Risk management is the systematic process of identifying and addressing potential risks associated with software development, updates, and implementation.

Risk management actions should be performed to determine the impact of the software application on product quality and data integrity.

A comprehensive risk assessment and control process identifies and documents all potential risks, serving as input for developing a risk-based test plan and executing effective test cases.

The risks can be related to the software’s functionality, performance, security, and usability.

The ISPE GAMP5 guidance document provides a risk-based approach to compliant GxP computerized systems.

The GAMP5 aims to deliver a cost-effective framework of good practices to ensure that computerized systems are effective, high-quality, fit for intended use, and compliant with applicable requirements.

SimplerQMS is fully validated according to ISPE GAMP5 and undergoes revalidation for each new version or standard update.

2. Validation Planning

The validation plan is a document that outlines the system scope, development methodology, validation measures, and associated procedures.

The validation plan guides the process of ensuring that a software system meets its intended purpose and complies with relevant requirements. It serves as a roadmap for conducting validation activities and provides a framework for measuring the success of these efforts.

3. Installation Qualification (IQ)

Installation qualification is confirmed through documented evidence that the installation of all system components adheres to the established specifications.

The installation qualification verifies that items such as equipment, instruments, computer system components, measuring devices, and more are installed following the approved design, the manufacturer’s recommendations, and user requirements.

4. Operation Qualification (OQ)

Operational qualification ensures that the system or subsystem operates correctly and produces the expected results over all the anticipated operating ranges.

Appropriate operational qualification should demonstrate the suitability of computer hardware and software to perform assigned tasks.

In major software updates, OQ confirms the system’s readiness for stricter performance tests, ensuring its functionality before deployment.

5. Performance Qualification (PQ)

The performance qualification verifies that each component in a computer system works as intended and meets performance requirements. It ensures the system can handle its workload and deliver reliable results.

Performance qualification is typically conducted for major software version upgrades.

6. Validation Reporting, including the Validation Certificate

A validation report is a comprehensive document summarizing the results of a system’s validation process. It serves as a tangible record of the entire validation effort, documenting activities, findings, and, ultimately, the system’s suitability for its intended use.

Importantly, no critical issues can remain open for the system to be validated.

After a successful software validation, the validation certificate is issued. A validation certificate is a formal document stating a system has passed all validation tests and meets its intended use requirements.

We recommend watching the video below for a comprehensive overview of an eQMS validation process.

What Are the Benefits of QMS Software Validation?

The primary benefits of QMS software validation include confirming the proper functionality of the software as intended and adhering to regulatory requirements for compliance.

Below are other benefits of QMS software validation.

High Level of Security

QMS software validation helps to identify potential security risks associated with the software. Validation ensures that the software operates consistently within defined parameters, minimizing risks related to software failure or functional errors that could impact product quality or patient safety.

Comprehensive and Continuous Software Testing

Electronic quality system validation ensures that critical systems are thoroughly and continually tested. This is important because systems can change over time, and the testing process needs to be updated to reflect these changes.

Continuous testing helps to identify and fix any defects or errors before they cause larger issues in daily use.

Effective Risk Assessment

EQMS validation includes assessing potential risks associated with the software. The proactive approach to identifying and mitigating risks minimizes the probability of errors or failures that could impact product quality and safety.

Enhanced Reliability

A validated QMS software is generally more reliable because it has undergone rigorous testing. This ensures that all functions work as intended in different scenarios and conditions.

Data Integrity

Validation processes include steps to ensure that data is accurately recorded and maintained, thereby improving the overall integrity of the data.

The benefits of QMS software validation are numerous and far-reaching. Maintaining a validated QMS software is essential for any Life Science company wanting to achieve these benefits.

What Is the Role of Fully Validated eQMS Software?

The main role of fully validated eQMS software is to help ensure regulatory compliance and quality assurance across all organizational processes.

Validated quality management software is a centralized system streamlining quality processes and storing relevant documentation. It helps ensure that the company complies with internal and external requirements.

Companies have three options for QMS software validation, as listed below.

• Do it themselves.
• Outsource to a service provider.
• Use fully validated QMS software like SimplerQMS.

The best option for each company will depend on its specific needs and requirements.

However, validating QMS software yourself can be challenging, as it involves a manual process that can be time-consuming and costly. Outsourcing to specialized service providers can also be expensive.

On the other hand, fully validated QMS software can provide everything a company needs and give the peace of mind of using a validated system that saves time, costs, and work in validation and revalidation tasks.

SimplerQMS provides a fully validated eQMS according to ISPE GAMP5. We maintain our software in a validated state by updating it whenever new versions or changes are introduced. SimplerQMS handles all validation tasks for our customers.

In addition to being ISPE GAMP5 validated, our platform supports compliance with several Life Science requirements such as ISO 9001:2015, ISO 13485:2016, FDA 21 CFR Part 11, 210, 211, 212, and 820, EU GMP Part I, EU GMP Annex 11, and more. SimplerQMS software helps companies achieve regulatory compliance by providing comprehensive QMS process support.

Our solution supports QMS processes, including document management, change control, employee training, deviation management, CAPA management, customer complaint management, audit management, supplier management, and more.

If you are unsure about the benefits of implementing an eQMS, we recommend using our eQMS Business Case template. This tool will help you assess the value of eQMS for your company and present your findings to management.

The template provides a structured approach to evaluating aspects such as cost savings, improved efficiency, and enhanced regulatory compliance.

Final Thoughts

QMS software validation is essential to ensure that the quality management system software works as intended and to comply with regulatory requirements for companies in regulated industries.

QMS software validation can be done by the company itself or by an outsourced service provider. However, both of these options can be labor-intensive and expensive.

A better alternative is to implement already validated software, which can save you time and costs and give you peace of mind knowing that the software is fit for purpose.

SimplerQMS provides a fully validated eQMS solution according to ISPE GAMP 5.

The software is kept in a validated state continuously, and SimplerQMS handles all validation and revalidation tasks on your behalf. This means you do not have to worry about anything and can focus on using the software to improve your quality management.

You can book a free demo with one of our quality experts to learn more about how our QMS software can help you streamline quality process management in your company.

The post QMS Software Validation: Everything You Need to Know appeared first on SimplerQMS.