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.

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.

The QMS includes all aspects of design and development, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and other areas.

Medical devices have different classes based on their risk to the end user. Specific regulatory requirements are applicable depending on the device classification to ensure safe and reliable products.

A medical device QMS needs to reflect the applicable requirements of a company’s processes to help ensure regulatory compliance.

This article will discuss a medical device quality management system, its purpose, some of the main regulatory requirements, and the role of an eQMS in helping streamline processes and maintain a compliant medical device quality system.

In this article, we will be looking at the following:

• What Is a Medical Device Quality Management System (QMS)?
• Purpose of Medical Device Quality Management System
• International Standards and Regulations Governing Medical Device QMS
• Major Medical Device QMS Processes
• Role of Medical Device Quality Management Software
• Frequently Asked Questions (FAQs) About Medical Device QMS

What Is a Medical Device Quality Management System (QMS)?

A Medical Device Quality Management System (QMS) is a structured system that documents the procedures and processes implemented throughout the lifecycle of a medical device.

A medical device QMS is essential to ensure quality in developing, manufacturing, and distributing processes.

As a manufacturer of medical devices planning to sell your products in the international market, you are required to implement and maintain a quality management system compliant with applicable international and national standards, guidelines, and regulations.

This requires establishing quality processes and assigning responsibilities, resources, and timeframes for each process.

Some of the main QMS processes for medical device manufacturers include document control, change control, employee training, audit management, CAPA, supplier management, risk management, and complaint handling.

Quality Management System (QMS) can be implemented using paper documents or eQMS software.

Medical device manufacturers can manually manage their QMS if they have the resources to handle manual paperwork.

But with the increasing number and complexity of regulatory requirements, managing all quality processes relying on manual paperwork can become challenging.

Many companies are migrating to eQMS and taking advantage of the benefits, including improved workflows, reduced time and costs, and cloud-based document storage.

SimplerQMS offers an eQMS solution designed for the medical device industry to help companies streamline their quality processes and achieve compliance. We provide interconnected QMS modules for more streamlined control and management of documents, changes, employee training, nonconformances, CAPAs, suppliers, and many other processes.

Purpose of Medical Device Quality Management System

The purpose of a medical device quality management system is to ensure that products are safe and effective for their intended use.

A QMS provides a framework for consistent and documented processes throughout the product lifecycle, from design and development to post-market surveillance.

Implementing and maintaining a QMS for medical devices is critical for manufacturers seeking approval from regulatory authorities in their intended market.

In Europe, having a QMS is required to obtain the CE marking and be able to sell your device across the European Economic Area. It is necessary to achieve compliance with the applicable EU regulations, such as the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).

You can learn more about how to obtain CE marking for medical devices in our step-by-step guide.

The Food and Drug Administration (FDA) has set forth current good manufacturing practice (cGMP) requirements for medical device quality management systems in the United States.

These requirements are outlined in the 21 CFR Part 820, also known as Quality System Regulation (QSR). They must be implemented throughout the product lifecycle.

International Standards and Regulations Governing Medical Device QMS

There are numerous international standards and regulations governing medical device quality management systems.

This article will focus on two major international markets, Europe and the United States.

Medical device manufacturers marketing and selling in the EU will most likely comply with ISO 13485:2016 standard, MDR, and IVDR for requirements for quality management systems.

On the other hand, manufacturers selling in the US will comply with the FDA’s regulation 21 CFR Part 820, also known as Quality System Regulations (QSR).

Let’s take a brief look at the major standards and regulations that you must be aware of:

• ISO 13485:2016 Standard
• Medical Device Regulation (MDR)
• In Vitro Diagnostic Regulation (IVDR)
• FDA 21 CFR Part 820 Regulation

ISO 13485:2016 Standard

The International Organization for Standardization (ISO) is responsible for the international regulatory standard ISO 13485:2016. It specifies the requirements for a QMS that can be used by organizations involved in the life cycle of a medical device.

Manufacturers that comply with this standard demonstrate their ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements.

You can read our article to learn more about an ISO 13485:2016 compliant QMS. It discusses the purpose of the ISO 13485:2016 standard, the main QMS requirements, and the role of eQMS in supporting compliance.

And if you want to know specifically about audits, check out our ISO 13485:2016 audits article for an overview of different types of audits and the execution process.

Medical Device Regulation (MDR)

The Medical Devices Regulation (MDR), or EU 2017/745, specifies the requirements for designing, manufacturing and distributing medical devices and accessories for human use in the EU.

The MDR requires medical device manufacturers to establish and maintain a comprehensive QMS to ensure compliance.

Although not mandatory in the MDR, manufacturers often use compliance with the ISO 13485:2016 standard since it presumes compliance with QMS requirements presented in the regulation. Which can help speed up the MDR certification process.

You can learn more about this regulation by reading our article on EU MDR Quality Management System.

In Vitro Medical Device Regulation (IVDR)

The In Vitro Diagnostic Medical Devices Regulation (IVDR) is the most common way to refer to Regulation (EU) 2017/746.

The IVDR has more stringent requirements for manufacturers of in vitro diagnostic devices, including a focus on risk-based classification, performance evaluation, and post-market surveillance.

It also requires manufacturers of in vitro diagnostic devices to implement a QMS that ensures compliance with the essential principles of safety and performance.

Like the MDR, the IVDR also recognizes compliance with ISO 13485:2016 for QMS requirements.

Feel free to read our article to learn more about EU IVDR in a detailed introduction.

FDA 21 CFR Part 820 Regulation

The 21 CFR Part 820 is a regulation of the US Food and Drug Administration (FDA) that outlines the Quality System Regulation (QSR) requirements for medical device manufacturers.

This regulation specifies the minimum requirements for a medical device QMS to ensure that devices are safe and effective for their intended use.

Compliance with 21 CFR Part 820 is mandatory for all medical device manufacturers who wish to sell their products in the US market.

Our article on the FDA 21 CFR Part 820 Quality System Regulation – provides more information regarding this regulation and the role of eQMS in supporting compliance.

Additionally, other requirements must be considered when implementing a quality management system using a computer system, such as QMS software or an eQMS.

This includes ensuring the software is validated and all necessary security measures are in place to prevent unauthorized access and data tampering, among other things.

The software should also be periodically reviewed and updated to ensure it remains compliant with regulatory requirements.

Relevant requirements concerning a QMS system validation are the following:

• FDA 21 CFR Part 11
• EU GMP Annex 11
• ISPE GAMP5
• ISO 13485:2016 Clause 4.1.6
• FDA 21 CFR Part 820.70(i)

FDA 21 CFR Part 11

The 21 CFR Part 11 regulates how electronic records are created, modified, maintained, and stored.

It specifies the requirements to ensure the accuracy and security of electronic records, including the validation of open and closed systems.

This regulation also sets the guidelines for electronic signatures, which are legally binding and serve as an equivalent to traditional handwritten signatures.

You can read our article on the 21 CFR Part 11 requirements to learn more about this regulation.

EU GMP Annex 11

The EU GMP Annex 11 provides Good Manufacturing Practices (GMP) guidelines for computerized systems.

It specifies the requirements to ensure computer systems do not cause a reduction in product quality, process control, or quality assurance, nor increase the overall risk of the process.

The validation documentation must contain change control records and reports on any deviations detected during the validation process.

Having an updated inventory of all relevant systems and their GMP functionality is also important.

ISPE GAMP5

The Good Automated Manufacturing Practice 5 (GAMP5) is a guideline developed by the International Society for Pharmaceutical Engineering (ISPE) for computerized systems.

It provides a risk-based approach to the validation and maintenance of computerized systems to ensure their accuracy, reliability, and consistency.

SimplerQMS software is fully validated according to ISPE GAMP5. It is re-validated upon creating a new version or applying standard updates. This helps you to save time to focus on more value-added activities.

Our solution also complies with FDA 21 CFR Part 11 and EU GMP Annex 11 for electronic records, electronic signatures, and computerized system manufacturing guidelines.

ISO 13485:2016 Clause 4.1.6

Clause 4.1.6 in the ISO 13485:2016 establishes that the medical device manufacturer must document procedures for validating computer software used in the QMS before initial use and after any changes to the software.

The specific approach and activities for software validation and revalidation should correspond to the risk associated with its use.

FDA 21 CFR Part 820.70(i)

The 21 CFR Part 820 section 70(i) also specifies that manufacturers must validate computer software for its intended use according to an established protocol.

All software changes must be validated before approval and issuance, documenting all validation activities and results.

Major Medical Device QMS Processes

We will focus only on some of the major medical device QMS processes in accordance with international standards and regulations – the ISO 13485:2016 standard and the FDA 21 CFR Part 820 regulation.

Among several QMS processes, some of them are mentioned in both ISO 13485:2016 and FDA 21 CFR Part 820. This section will briefly discuss only some of these quality processes and their requirements.

According to these, the major medical device quality management requirements can be summarized as given in the following subsections:

• Document Control
• Training Management
• Audit Management
• CAPA Management

Document Control

Your medical device quality management system should include processes and procedures for managing the many different documents that move within your company, amongst sponsors, investors, and regulatory agencies throughout the lifecycle of your product.

This entire process is referred to as document control.

Over the past decade, many manufacturers have migrated from traditional paper-based QMS to automated medical device quality management software with robust document control capabilities.

Such software automatically collects data, routes documents for review and approval processes of various documents, and stores them in a single storage location.

QMS software, such as SimplerQMS, provides automatic version control, which ensures that only the latest version of the documents is in circulation.

SimplerQMS offers pre-configured workflows to simplify document control. You can easily create documents using forms or document templates and route them for review as often as needed. After the final version of a document is approved and released, employees are automatically notified.

Moreover, if you want to know more about document control, read our articles on Quality Management System Documentation and Medical Device Document Control.

Training Management

International regulations and standards such as the FDA 21 CFR 820 and ISO 13485:2016 require medical device manufacturers to have specifically trained and competent employees doing their job.

This means that all training procedures must be constantly evaluated, and all employee training records must be appropriately maintained.

For instance, changes to the manufacturing process of medical devices must be learned by all personnel involved. This means companies must provide training and assess the training effectiveness to ensure employees have the skill to perform their duties.

SimplerQMS provides training management software to help streamline the entire training process. From assigning training tasks to specific employees, distributing training material, and tracking all training activities, to providing quizzes to measure training effectiveness.

Audit Management

The FDA 21 CFR 820 and ISO 13485:2016 require medical device manufacturers to establish a proper audit process and conduct regular quality audits.

This is to ensure that the medical device quality management system as a whole is compliant.

Companies need to properly audit all the applicable requirements for a medical device to ensure compliance regarding product safety and efficacy.

The audit management module by SimplerQMS facilitates the entire audit process. You can schedule activities, set due dates, send automatic notifications to the right personnel, and track employee performance related to their assignments.

Whenever an audit finding occurs, you will be able to easily link it to a nonconformance case, supplier corrective action request (SCAR), or escalate to corrective action and preventive action (CAPA).

You can read our article on medical device audits to learn more about the different audits in the medical device industry.

CAPA Management

As per the FDA 21 CFR 820 and the ISO 13485:2016 requirements, all manufacturers of medical devices must implement the process of managing corrective actions and preventive actions (CAPA). 

The CAPA process is essential to resolve and prevent issues that are likely to impact the quality of the product, such as nonconformances, audit findings, complaints, etc. Additionally, all actions must be documented adequately and resolved in a timely manner.

Key CAPA process steps are illustrated below.

With the SimplerQMS CAPA management software, you can streamline the entire CAPA process by automating data collection, routing, follow-ups, notifications, approvals, and escalation of overdue activities.

You can quickly initiate CAPA forms directly from issues, such as nonconformances or deviations, audit findings, and customer complaints.

The system automatically enters data from the metadata in the CAPA form to reduce human error. It also enables you to relate documents in scope and eliminates the need to circulate documents or chase signatures manually.

Check out our article to better understand what CAPA is in the medical device industry.

In addition to the quality processes mentioned in this section, several other processes are required as per standards and regulations, such as ISO 13485:2016 and FDA 21 CFR Part 820.

Some of these include:

• Change management
• Complaint management
• Nonconformance management
• Equipment management
• Supplier management

This article does not cover all sections above. Companies should always verify which processes are relevant to them and comply with the specific requirements that apply to their business.

Role of Medical Device Quality Management Software

A medical device quality management system is essential for ensuring products are safe and effective for their intended use.

It is a requirement of many standards and regulations that medical device companies have a compliant QMS.

Companies can have a paper-based or hybrid QMS by implementing a manual system. The latter approach may be adequate for small companies with adequate resources, but it can be time-consuming, prone to errors, and challenging to maintain compliance with regulatory requirements.

Electronic QMS provides an alternative solution that offers greater efficiency and accuracy, making it a robust option for numerous companies.

Medical device manufacturers can use such software to manage quality processes throughout the product lifecycle, from design and development to manufacturing, labeling, distribution, and corrective and preventive actions.

The benefits of medical device quality system software include the following:

• Ensure compliance with regulatory requirements using pre-configured workflows
• Improve customer satisfaction by addressing issues in a timely manner
• Save time with automated documentation processes
• Ensure traceability with automated data collection and flexible linking capabilities
• Improve communication and collaboration across departments
• Reduce the risk of inaccuracies by mitigating human errors associated with manual data entry

SimplerQMS provides an eQMS designed for the medical device industry. Our software streamlines quality processes and helps companies in achieving compliance with regulatory requirements.

We offer robust document management capabilities that simplify document creation, versioning, review, approval, and search within one secure location.

Our QMS modules are interconnected and allow for easy linking of complaints, CAPAs, training, and other quality management processes.

The SimplerQMS system is fully validated in compliance with ISPE GAMP5 and undergoes revalidation for each new version or standard update.

It also complies with FDA 21 CFR Part 11, which sets the guidelines for electronic signatures and electronic records, and EU GMP Annex 11, which provides good manufacturing guidelines for computerized systems.

Now that you are aware of the benefits of an eQMS in terms of compliance and streamlined workflows, it is important to consider the associated time and cost savings.

Understanding these factors will help you make an informed decision about whether to allocate a budget for an eQMS and move forward with implementation.

We recommend downloading our eQMS Business Case template. This tool will help you provide decision-makers with concrete evidence of the benefits of implementing an eQMS and make a compelling case for the investment.

Frequently Asked Questions (FAQs) About Medical Device QMS

What Are the Two Main Quality Systems Adopted by Medical Device Manufacturers?

The two main quality systems medical device manufacturers adopt are the FDA 21 CFR 820 and the ISO 13485:2016.

The FDA 21 CFR 820 sets the requirements for quality management systems in the US, while ISO 13485:2016 is an international regulatory standard that outlines the requirements for QMS for medical devices in the EU and other countries.

What is the Best Quality Management Software for Medical Devices?

The best medical device QMS software for your company will depend on various factors, such as the size and complexity of your company, applicable specific requirements, available time, and budget.

QMS software solutions are available for Life Science companies in the medical device, pharmaceutical, biotechnological, and other industries. Each solution has unique features and qualities, so it is essential to consider your company’s specific needs and regulatory requirements.

The chosen software should be easy to use and provide good customer support to help with any doubts or problems that may arise. For a more straightforward evaluation, there is a compiled list of the 6 best QMS software solutions for Life Sciences options available.

Additionally, our QMS software comparison template can be used to compare shortlisted options and select the best one for your company or as a reference to develop a list of requirements for quality management software.

What Is the ISO 13485:2016 Quality Management System?

The ISO 13485:2016 QMS standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that constantly meet customer and applicable regulatory requirements.

You can learn more about this international regulatory standard in our article on ISO 13485:2016 Compliant QMS.

When Is a Quality Management System (QMS) Required for Medical Devices?

Medical device companies require a Quality Management System (QMS) when registering devices for marketing and selling.

Compliance with FDA 21 CFR Part 820 is required for operating in the US market, and medium to high-risk devices must go through the 510(K) process.

In Europe, obtaining the CE marking is required for marketing and selling devices, and certification to ISO 13485:2016 can be used to comply with the QMS requirements of the MDR or IVDR.

When Should I Start Building a Medical Device QMS?

Timing is crucial when building a QMS.

Starting the QMS during the early prototype phase or idea testing can put unnecessary constraints on development. Sufficient research and knowledge should be obtained before building the QMS.

However, it is also not advisable to wait too long to build the QMS, as it takes time to develop a suitable system.

The ideal time to start building a medical device QMS is when enough information and knowledge have been gathered to ensure an efficient QMS development process. This can be around the Design and Development phase.

How Long Does It Take to Fully Implement Medical Device QMS?

It typically takes 3 to 9 months to fully establish a medical device QMS. Still, medical device consultants suggest starting preparations at least 18-24 months before commercialization.

Using a document template for processes and protocols is advantageous and can help speed up the implementation.

SimplerQMS offers a customizable document template package based on Life Science requirements, such as ISO 13485:2016, to simplify the creation of documents and streamline your quality documentation processes by managing forms and templates effectively.

Final Thoughts

The medical device quality management system is a regulatory requirement for manufacturers of medical devices. The quality management system covers all aspects of the medical device’s lifecycle.

It is a regulated framework comprising strategies and procedures for the design, clinical data, manufacturing, storage and distribution, supplier management, complaints, labeling, and other aspects of your medical devices.

SimplerQMS medical device QMS software streamlines your quality management processes by managing routine documentation tasks, enabling you to achieve greater efficiency while making compliance easier.

If you are looking for a comprehensive QMS software solution to manage quality processes more effectively, schedule a demo presentation to see SimplerQMS in action and talk to our experts.

The post Medical Device Quality Management System (QMS) appeared first on SimplerQMS.

The IVDR was introduced in May 2017 to improve the safety and efficacy of in vitro diagnostic medical devices available in the EU market.

A comprehensive quality management system (QMS) supports manufacturers of in vitro diagnostic medical devices to comply with the IVDR requirements regarding quality.

This article will discuss IVDR, its purpose, the rules for the device classification, some of the QMS requirements, and the role of electronic QMS (eQMS) in supporting compliance with IVDR. We will also give examples that illustrate the important role played by eQMS.

SimplerQMS has helped dozens of Life Science companies transition to a modern electronic QMS system and realize its associated benefits, including easier regulatory compliance. If you want to learn more about how an eQMS can help you streamline quality management processes, book a personalized demo.

Learn more about EU IVDR in the following topics:

• What is EU IVDR?
• What Is The Purpose of EU IVDR?
• IVDR Device Classification
• EU IVDR QMS Requirements
• Frequently Asked Questions About EU IVDR
• The Role of QMS Software in Supporting Compliance With EU IVDR

What is EU IVDR?

The EU IVDR stands for European Union In Vitro Diagnostic Regulations and is the most common way of referring to Regulation (EU) 2017/746.

The IVDR specifies the requirements for placing in vitro diagnostic medical devices and their accessories on the EU market.

It defines an in vitro medical device as any device used in vitro to examine samples derived from the human body to provide relevant information for diagnostic purposes. These can be a reagent, product, calibrator, control material, software, or system used alone or in combination.

This regulation was introduced in May 2017 and has a transition period for manufacturers to comply with the requirements until May 2025 to May 2028, depending on device classification.

Manufacturers of medical devices that wish to place in vitro diagnostic medical devices on the EU market must comply with EU IVDR requirements.

EU IVDR vs. IVDD

EU IVDR replaced Directive 98/79/EC, also known as the In Vitro Diagnostic Directive (IVDD).

Since the IVDD was first issued in 1998, some of its requirements are not aligned with current knowledge of in vitro medical devices.

The IVDD and IVDR share the same basic regulatory process. But IVDR specifies comprehensive requirements for in vitro diagnostic medical devices.

The IVDR adds requirements, such as greater attention to risk management, device classification, reporting to authorities, device traceability, post-market surveillance system, and so on.

Lastly, the IVDD is a directive, and manufacturers could choose to comply with its requirements. However, IVDR is a regulation, so compliance with requirements is mandatory.

EU IVDR vs. EU MDR

Together with IVDR, the European Parliament introduced the Regulation (EU) 2017/745, known as the Medical Device Regulation (MDR).

The MDR specifies requirements to place medical devices in the EU market. It refers to a broad category of medical devices. However, it does not apply to in vitro diagnostic devices, being the requirements for these specified in the IVDR.

So, medical device manufacturers in the EU must comply with the requirements specified in MDR or IVDR, depending on their device type.

The IVDR relates to MDR in many aspects, for instance, concerning the identification and traceability of devices, conformity assessment by Notified Bodies, QMS requirements, and risk management.

The difference between IVDR and MDR can be observed in the clinical evidence needed to demonstrate conformity. For IVDR, clinical evidence, performance evaluation, and performance studies are required. While in MDR, manufacturers must conduct and document clinical evaluation and clinical investigation.

If you want to know more about MDR and how an eQMS can help you achieve compliance with it, read our article on the EU MDR Quality Management System, and the role of an eQMS.

What Is The Purpose of EU IVDR?

The purpose of EU IVDR is to help ensure in vitro diagnostic medical devices placed on the EU market are safe and effective.

The IVDR is part of the overall EU regulation for medical devices. It specifies the requirements manufacturers must comply with in order to sell and market an in vitro diagnostic medical device in Europe.

Compliance and certification to this regulation allow companies to commercialize their products across the European Economic Area. The only exception is devices used exclusively for research, where IVDR does not apply.

For instance, a company that manufactures self-testing devices, such as pregnancy tests or HIV detection assays, must comply with the IVDR and be certified before selling in the EU.

IVDR Device Classification

The IVDR classification rules in Annex VIII specify four classes for in vitro diagnostic devices: A, B, C, or D. These classes are based on the intended purpose of the devices and potential risk for end-users.

• Class A: Have low patient and public health risks. They include laboratory instruments, buffer solutions, and specimen receptacles.
• Class B: Have moderate patient risk and low public health risk. They include pregnancy tests and glucose level tests.
• Class C: Have high patient risk and moderate public health risk. They include sexually transmitted infection tests, cancer markers, and human genetic tests.
• Class D: Have both high patient risk and high public health risk. They include blood groupings, such as ABO and the Rhesus system.

Under the IVDR, only class A non-sterile devices can be self-certified by the manufacturer.

Before marketing, in vitro diagnostic devices from the remaining classes must be audited and certified by a Notified Body.

EU IVDR QMS Requirements

The IVDR has several articles to cover all requirements for in vitro diagnostic medical devices. Among them, the regulation specifies that manufacturers who wish to place their devices on the EU market must implement and maintain a Quality Management System (QMS).

The following topics are some examples of where an efficient QMS can help companies achieve compliance with the IVDR QMS requirements:

1. General safety and performance requirements
2. Technical documentation
3. Responsibility of management
4. Resource management
5. Risk management
6. Post-market surveillance
7. Unique Device Identification (UDI)
8. Reporting to authorities
9. CAPA management

1. General Safety and Performance Requirements

Manufacturers must ensure their devices achieve the performance intended during normal conditions of use. For that, devices need to be designed and manufactured to be suitable for the proposed safety and performance.

To comply with this requirement, design, development, and manufacturing documentation must be planned and controlled. As a result, in this stage, a high volume of documents is generated.

SimplerQMS Design Control Software facilitates document creation with a document template package based on Life Science requirements and pre-configured workflows to guide you through the process.

The system offers Life Science companies the capability of storing data in a cloud-based repository,  defining access levels to documents, relating documents to products, escalating issues to CAPA, and more.

2. Technical Documentation

The technical documentation must be presented in a clear, organized, readily searchable, and precise manner.

It includes several documents, such as device description and specification, reference to previous and similar generations of the device, labels used on the device and its packaging, and so on.

Manufacturers can use Document Control Software, such as the one integrated into the SimplerQMS solution, to help streamline the process of reviewing and approving documents. This core QMS module helps keep documents audit-ready while accurately controlling a high volume of data.

To know more about how to handle documents, read our article about medical device document control.

3. Responsibility of Management

Among many responsibilities, top management must communicate the importance of an effective QMS and the regulatory requirements to all employees. Management will establish the quality policy and objectives of the company.

It is the top management’s responsibility to ensure the effective implementation of the QMS to achieve compliance with IVDR quality systems requirements.

Using an electronic QMS solution like SimplerQMS, you benefit from a single cloud-based system that allows easy access to all QMS data.

The system automatically creates a record of all activities inside the software and provides a time-stamped audit trail. You can easily search and retrieve documents, create customizable document status views, and export data for further analysis.

4. Resource Management

Manufacturers must have a QMS to address resource management to provide adequate resources for conformity assessment activities.

Resource management includes infrastructure, workforce, and suppliers.

For instance, an important infrastructure element is an equipment used in manufacturing the devices. This equipment needs to be adequately maintained to prevent any issues that can impact product safety and quality.

SimplerQMS provides equipment management software to simplify equipment calibration and maintenance tasks. You can create periodic calibration or review tasks, monitor equipment status, set up automatic reminders of actions before due dates, relate specific products to specific equipment, and more.

Another important requirement is having a trained workforce with the necessary skills to perform their functions efficiently. For example, the employees must know the related procedure to use specific equipment, ensuring the tasks are done consistently.

Life Science companies must have a training plan to ensure all employees are competent to perform their specific activities. Training management is one of the core QMS processes in SimplerQMS and helps companies streamline the training process with learning rules, training groups, task assignments, and quizzes.

Regarding suppliers, implementing an eQMS can help medical device companies manage and monitor their suppliers more effectively. SimplerQMS Supplier Quality Management Software allows you to create and maintain Approved Supplier List, schedule supplier audits, and set up automatic reminders for tasks before due dates.

Read our article on the medical device supplier management process to learn more.

5. Risk Management

In vitro diagnostic devices need to be safe and effective for end-users. So, mitigating risks as far as possible is required without adversely affecting the benefit-risk ratio.

The QMS must have risk identification, assessment, and mitigation procedures throughout an in vitro diagnostic device lifecycle.

A complete eQMS, like SimplerQMS, support you with risk management documentation management. You can relate risk documents to products, components, suppliers, customers, equipment, etc. Easily export data and create a traceability matrix and improve risk mitigation.

6. Post-Market Surveillance

Post-market surveillance (PMS) for medical devices is a process by which manufacturers assess the safety and efficacy of their in vitro diagnostic devices in the market.

This requires manufacturers actively gather information regarding their product after it has been sold. Information can be in the form of customer complaints, a literature search on similar devices, and an evaluation of competitors’ issues.

Any quality events need to be addressed within a proper time frame.

SimplerQMS is a comprehensive eQMS that can help you streamline your complaint management workflow.

The system offers features such as document creation using a template package based on Life Science requirements, relating complaint documents to customers or products, setting reminders for task due dates, escalating issues to CAPA, etc.

To learn more check out our article on medical device complaint handling processes.

7. Unique Device Identification

The Unique Device Identification (UDI) is an exclusive numeric or alphanumeric code placed on every medical device in the market, including in vitro diagnostic devices.

The UDI is essential for tracing legal devices that are in conformity and certified to IVDR requirements.

The European Database on Medical Devices (EUDAMED) stores the UDI list, where are all crucial information about the device, such as manufacturers’ details, device risk class, market status, certificates, and more.

8. Reporting to Authorities

According to IVDR, the QMS must have proper procedures for handling communications with competent authorities, Notified Bodies, customers, and other stakeholders.

Regarding reporting to authorities, Life Science companies must summarize the results and conclusions of the analyses of the PMS data and report them together with a rationale and description of any corrective and preventive actions taken.

SimplerQMS offers a reporting functionality where you can justify actions taken and summarize reports. This feature can be enabled or disabled depending on your compliance needs to streamline the workflow.

9. CAPA Management

The QMS should have a robust system for managing corrective and preventive actions (CAPAs) regarding quality events, helping to justify the actions taken and verify their effectiveness.

SimplerQMS supports a comprehensive CAPA management software that can track and manage CAPAs to enforce continuous improvement and resolve issues in a timely manner.

The system offers companies best-practice document templates based on Life Science requirements for complaints, non-conformances, and CAPAs. You can streamline processes with our pre-configured workflows while the system automatically records all actions taken in a time-stamped audit trail.

To learn more about the CAPA process, read our article on the CAPA management process in the medical device industry.

Frequently Asked Questions About EU IVDR

What Does EU IVDR Replace?

The European Union’s In Vitro Diagnostic Regulations (EU IVDR) replaces the In Vitro Diagnostic Directive (IVDD).

The IVDR was implemented in May 2017 and has a transition period until May 2025 to May 2018, depending on the in vitro diagnostic device classification.

Is ISO 13485:2016 Required for EU IVDR?

The ISO 13485:2016 standard is not required for IVDR. However, many manufacturers of in vitro diagnostic devices usually comply with this standard since following it presumes compliance with QMS requirements presented in the IVDR.

What Is the Main Difference Between EU MDR and EU IVDR?

The main difference between EU MDR and EU IVDR is that MDR requirements apply to all medical device types for human use, except in vitro diagnostic devices.

The IVDR is specific for in vitro diagnostic medical devices placed on the EU market.

What Is the Main Difference Between EU IVDR And IVDD?

The main difference between EU IVDR and IVDD is that IVDD is a directive with voluntary compliance, while IVDR is a regulation and so mandatory for every member state in the EU.

IVDR and IVDD have basic requirements in common, but IVDR is a more comprehensive regulation.

Which Countries Does IVDR Apply To?

The EU IVDR applies to all countries in the European Economic Area.

The Role of QMS Software in Supporting Compliance With EU IVDR

Manual paper-based or hybrid QMS have been used traditionally by companies to comply with Life Science regulations and standards requirements. These manual QMS can be successfully used when the company is small and has the necessary resources for the paperwork.

Nevertheless, when considering current regulatory requirements, such as those presented in IVDR, it is evident that manual paper-based and hybrid QMS are becoming increasingly insufficient. These systems bring their own challenges, for instance, physical storage problems, security issues, lost files, and so on.

So, implementing modern, reliable, and efficient QMS software for medical devices, such as SimplerQMS, facilitates quality management. An eQMS provides many features to help achieve compliance with IVDR requirements, streamline QMS processes, enhance efficiency, and lower costs.

Some of the best QMS software solutions for life sciences provide companies with robust and comprehensive QMS modules for document control, change management, employee training, CAPA and non-conformances management, customer complaints handling, supplier management, internal and external audits management, and much more.

SimplerQMS is a state-of-the-art document management system. The system is fully validated according to GAMP5 with monthly re-validation and FDA 21 CFR Part 11 and EU Annex 11 compliant regarding electronic signatures. Our solution covers all Life Science QMS modules in one single place.

Download our eQMS Business Case template to understand the investment in quality management software. The template will assist you in quantifying the investment in an eQMS and help you present it to your company’s decision-makers.

Final Thoughts

One of the most regulated industries in Life Science is medical devices. Due to the vital role medical devices play in patient care, including in vitro diagnostics, this is justifiable.

For instance, the European Centre for Disease Prevention and Control states that within the first two years of COVID-19, over 100 million cases were reported in Europe alone.

These high quantities indicate the number of diagnostic tests conducted across the EU. So, there is a need for strict control by international regulatory authorities.

To place an in vitro diagnostics medical device in the EU market, companies must comply with the requirements presented in the EU IVDR, including QMS requirements.

Many manufacturers choose to achieve compliance with ISO 13485:2016 standard first, as it is presumed to conform with IVDR requirements regarding QMS.

Traditional paper-based or hybrid QMS may still be used at small-sized organizations with sufficient personnel and resources. However, companies are now transitioning to modern and highly efficient eQMS solutions that will streamline the entire QMS process.

If you are interested in implementing an eQMS solution and simplifying achieving compliance with EU IVDR, book a demo of SimplerQMS and talk to our quality solution experts today.

The post What is EU IVDR? A Detailed Introduction (and Role of eQMS) appeared first on SimplerQMS.

Audits are conducted by Auditing Organizations approved by the Regulatory Authorities of the participating MDSAP members, including Australia, Brazil, Canada, Japan, and the United States.

The MDSAP is a way for medical device manufacturers to target multiple new markets and minimize business disruptions that can happen with several different regulatory audits.

In this article, we will discuss the MDSAP purpose, benefits, the participating regulatory authorities, the typical audit process, and how a modern Electronic Quality Management System (eQMS) can help your company prepare for the MDSAP.

An eQMS is one of the best ways to prepare for the MDSAP. SimplerQMS provides eQMS software for medical device companies to manage quality management processes, reduce workflow disruption, and make compliance easier to achieve. To learn more about how SimplerQMS can help your company book a demo and talk to one of our Quality Solution experts.

We will cover the following topics:

• What Is Medical Device Single Audit Program (MDSAP)?
• What Is the Purpose of MDSAP?
• What Are the Benefits of the MDSAP?
• Which Regulatory Authorities Are Participating in MDSAP?
• MDSAP Audit Cycle
• MDSAP Audit Process
• MDSAP Key Considerations
• Frequently Asked Questions
• The Role of eQMS Software in Preparation for MDSAP

What Is Medical Device Single Audit Program (MDSAP)?

The MDSAP is a program that allows medical device companies to face a single third-party audit conducted by authorized Auditing Organizations to satisfy the regulatory requirements of its participating members.

With MDSAP, medical device companies undergo a single audit for compliance with the regulatory requirements of five medical device markets: Australia, Brazil, Canada, Japan, and the United States.

What Is the Purpose of MDSAP?

The purpose of MDSAP is to accelerate international medical device regulatory harmonization and to promote an efficient and effective regulatory model.

The program was developed to enable a regulatory overview of medical device manufacturers’ QMS while reducing the regulatory burden on the industry. It aims to promote worldwide alignment of international requirements.

For instance, a medical device company sells 3-dimensional microscopes for reconstructive surgery. Complying with the requirements of MDSAP allows the company to market and sell the device in five major international markets.

What Are the Benefits of the MDSAP?

Being MDSAP certified presents many benefits to medical device manufacturers, patients, and regulatory authorities.

Benefits for medical device manufacturers:

• Single comprehensive audit: medical device companies can undergo a single audit process, not several individual audits. Being MDSAP certified reduces business disruptions and saves resources, such as time, finances, and training.
• Commitment to quality: MDSAP certification emphasizes to regulatory authorities and customers the company’s commitment to quality and compliance with international requirements.
• Predicted audit schedules: MDSAP has a comprehensive schedule for a three-year period. So, medical device companies have a clear understanding of their timeframes and resources.

Benefits for patients and end-users:

• Patient safety: By complying with MDSAP documents, medical device companies assure patients and end-users that all devices are safe and effective for the intended use.

Benefits for regulatory authorities:

• Multiple compliances: Regulatory authorities participating in the MDSAP are assured that auditing has been conducted in accordance with the agreed requirements. This reduces the workload of individual regulatory authorities.

Which Regulatory Authorities Are Participating in MDSAP?

The MDSAP is a program under the International Medical Device Regulators Forum (IMDRF).

IMDRF is a voluntary group of medical device regulators from around the world and aims to accelerate international medical device regulatory harmonization and convergence.

There are several countries in the IMDRF group. However, the international partners that are participating in the MDSAP include:

• Therapeutic Goods Administration of Australia
• Brazilian Health Regulatory Agency (Anvisa)
• Health Canada
• Ministry of Health, Labour and Welfare of Japan, and Japanese Pharmaceuticals and Medical Devices Agency
• US Food and Drug Administration

Therapeutic Goods Administration of Australia

The Australian Therapeutic Goods Administration (TGA) uses MDSAP audit reports and certificates as part of the evidence for compliance with medical device conformity assessment procedures and market authorization requirements.

Medical device manufacturers audited under MDSAP may, under some circumstances, avoid routine TGA inspections.

Brazilian Health Regulatory Agency (Anvisa)

Brazilian Health Regulatory Agency (Anvisa) utilizes MDSAP reports to constitute an important input on pre-market and post-market assessment procedures.

ANVISA may use MDSAP audits in place of a pre-market inspection for manufacturers intending to put higher-risk devices on the Brazilian market. For subsequent assessments, ANVISA continues to use its regular audits and inspections.

Health Canada

Health Canada started accepting MDSAP certificates at the beginning of January 2019.

This means that medical device companies do not have to undergo any additional audits in Canada regarding the QMS.

Japanese Regulatory Authorities

The Japanese Regulatory Authorities (Ministry of Health, Labour and Welfare of Japan, and Japanese Pharmaceuticals and Medical Devices Agency) accept MDSAP audit reports exempting some manufacturing sites from on-site inspection.

This reduces medical device manufacturers’ burden in QMS audit processes and may lead to the reduction of documentation required to be submitted for off-site inspection as well.

US Food and Drug Administration

The US FDA will accept the MDSAP audit reports as a substitute for FDA Establishment Inspection Reports (EIR).

The EIR describes what was observed during the FDA investigator’s visit to the company site, from introductions to inspectional observations.

It is worth mentioning that when US requirements are audited, FDA 21 CFR Part 820 for QMS regulation should appear on the certification document.

MDSAP Audit Cycle

The complete MDSAP has a three-year audit cycle consisting of the following:

• An Initial Audit (the Initial Certification Audit)
• Partial Surveillance Audits in years 2, 3
• Complete Re-Audit in year 3

The MDSAP audit model will review medical device companies’ QMS compliance with ISO 13485:2016 as well as the individual regulatory requirements of the participating countries where companies wish to market finished devices.

The Initial Audit will comprehensively audit the Medical Device Quality Management System.

It consists of two audit stages. The purpose of the Stage 1 Audit is a complete review of the QMS documentation required by ISO 13485:2016 and to evaluate preparedness for the next stage audit.

The goal of the Stage 2 Audit is to evaluate QMS implementation and effectiveness in accordance with ISO 13485:2016 and the requirements of the participating regulatory authorities.

A series of Surveillance Audits aims to ensure that all applicable requirements mentioned in the Initial Audit are continuously inspected during the three-year cycle.

Finally, a Re-audit (Recertification audit) aims to confirm the continued relevance, applicability, and suitability of the medical device company’s QMS as a whole. It can include a Stage 1 Audit if your QMS has undergone a critical change that was not sufficiently assessed previously.

In addition to these audits, medical device companies can undergo Special Audits that are not part of the planned audit cycle. A Special Audit may be conducted in response to an application to extend the scope of an existing certification, for example.

Another important audit is an Unannounced Audit. This audit can be conducted anytime during the three-year audit cycle. During this audit, the Auditing Organizations will randomly select a representative product and check whether it has been manufactured in accordance with your company’s QMS.

Recommended Reading

• ISO 13485:2016 Audit: Overview, Audit Types, and Execution
• Medical Device Audits: Overview and Tips

MDSAP Audit Process

This article will briefly discuss the MDSAP audit process.

We will also give examples of how an Electronic Quality Management System (eQMS), like SimplerQMS, can help your company successfully prepare for the MDSAP certification.

As stated before, the International Medical Device Regulators Forum (IMDRF) has recognized third-party auditors to conduct the MDSAP audit for medical device companies, known as Auditing Organizations (AO).

Each participating member has a list of approved AOs. For instance, the FDA has a list of recognized auditing organizations. Check each regulatory authority website to find the authorized AO list of your interest.

Four primary processes, one enabling process, and two supporting processes are part of the MDSAP audit.

Primary processes:

• Management
• Measurement, Analysis, and Improvement
• Design and Development
• Production and Service Controls

Enabling process:

• Purchasing

Supporting processes:

• Device Marketing Authorization and Facility Registration
• Medical Device Adverse Events and Advisory Notices Reporting

The auditors will start with the Management Process and then proceed to the second primary process, and so on.

The two supporting processes will fulfill the regulatory requirements of the participating jurisdictions.

Management Process

The top management of medical device companies must ensure that:

• Sufficient resources are provided for device design and manufacturing
• The quality management system is proper and effective
• Monitor the QMS and make adjustments when needed
• Define, document, implement, and maintain the QMS requirements via a representative.

It is essential that top management show commitment to quality. The quality commitment must be communicated across the company to assure employees and third-party stakeholders, such as the regulatory authorities and end-users, that finished medical devices are safe and efficient for their intended purpose.

The quality data obtained from different sources within and outside the company must be analyzed. With this information, companies can measure preparedness for the audit, make changes in processes if required, provide additional resources, and so on.

Collating data into a single source of truth is much easier using an eQMS system paired with powerful document controls such as SimplerQMS. It allows medical device companies to gather data from all departments and processes in a single cloud-based system.

Documents and related information can be easily linked, versioned, routed for review/approval, and retrieved during the audits.

Measurement, Analysis, and Improvement Process

In MDSAP, the QMS emphasizes identifying existing and potential causes of product and quality issues.

To take appropriate and effective corrective and preventive actions, these causes must be identified.

All these processes are carried out under the Measurement, Analysis, and Improvement process. Also, outcomes must be documented and reported to the relevant regulatory authority.

An eQMS solution helps medical device manufacturers manage nonconformance, complaint, and CAPA processes.

SimplerQMS software solution allows companies to keep track of all nonconformances, complaint resolution progress, CAPA status, and so on to easily manage and document all data with just a few clicks.

Design and Development Process

The Design and Development Process aims to control the design of a medical device and to assure that the device meets user needs, intended use, and its specified requirements.

The key steps that medical device companies are expected to follow are:

• Design and development planning: Have updated and approved plans for all manufactured medical devices.
• Design input: Have design input procedures to ensure the initial design for a given medical device corroborates with its actual use. A design must be reevaluated if there is ambiguity or incompleteness.
• Design output: Ensure the design output of every medical device conforms to the original design input.
• Design review: Monitor and conduct formal documented reviews of specific devices at selected intervals. Document the results in the Design History File (DHF).
• Design verification: Ensure the conformance of design output with design input with established QMS protocols.
• Design validation: Have compatibility between devices and related software with the intended use. Companies can use either stimulated or actual use conditions to validate.
• Design transfer: Ensure the device design is translated into correct product specifications.
• Design changes: Control design changes to improve the design of a medical device.
• Design history file: Use the medical device’s DHF to prove the device was manufactured following approved plans.

The design and development process requires creating, maintaining, validating, and circulating multiple files and documents between departments. This is easier to perform and track with an eQMS solution.

SimplerQMS’s design control software module helps medical device companies to keep all design control-related documents in one place, reducing the chances of errors due to manual paperwork.

Easily create documents using a template package based on Life Science requirements, link files to different design control archives without creating duplicates, assign tasks to specific people, drag and drop external documents inside the system, and migrate all existing files to a single cloud-based system.

Production and Servicing Controls

The purpose of auditing the Production and Servicing Control is to verify the development of processes used to manufacture products that meet specifications.

Medical device companies need to consider the processes regarding:

• Environmental controls: Any environmental changes can affect the finished device’s overall quality.
• Contamination controls: The manufacturing area of the plant and the equipment used must be clean and sterile, if applicable.
• Personnel controls: Staff health, cleanliness, and clothing need to be checked regularly.
• Building controls: Sufficient space should be available for every activity in the product lifecycle.
• Manufacturing materials control: Materials used for manufacturing specific devices must be suitably discarded if compromised in any way.
• Servicing controls: Determine if servicing activities are performed and documented following instructions and procedures.

This process emphasizes various crucial controls that are needed during the lifecycle of a medical device. Once more, an eQMS solution can help in ensuring these controls are in place.

With SimplerQMS, medical device companies can create document collections to compile technical documentation, DHF, DMR, and DHR. Our solution also allows companies to schedule periodic reviews of these documents, automatically notify relevant personnel when changes are made, and securely store all the needed documentation for each device in a cloud-based system.

Purchasing Process

The medical device company is expected to establish and maintain documented controls for planning and performing purchasing activities. This refers to third-party suppliers, including contractors and consultants, who supply components, materials, or services.

Using an eQMS solution with supplier quality management features, like SimplerQMS, facilitates selecting, evaluating, qualifying, and managing your suppliers.

You can create and maintain Approved Suppliers Lists (ASLs) and use templates based on Life Science requirements for various documents, such as contracts, surveys, evaluations, certificates, and incoming inspections. Easily assign and track supplier-related tasks while keeping the records of all suppliers secure in one place.

Recommended Reading: Medical Device Supplier Management Process (8 Steps)

Device Marketing Authorization and Facility Registration Process

Auditing these processes aim to verify that medical device companies performed the appropriate activities regarding device marketing authorization and facility registration with regulatory authorities participating in the MDSAP.

Medical Device Adverse Events and Advisory Notices Reporting

This process audit verifies that a post-market surveillance system is established and implemented in the medical device company and integrated into the QMS. Procedures and workflows are established to ensure the correct and prompt identification of adverse events.

For instance, a batch of implantable pacemakers is malfunctioning, and several healthcare facilities filed complaints. The company needs to identify the root cause of the issue, ensure it does not repeat it, and report to the relevant regulatory authority.

For that, medical device companies need the capability to continuously collect and analyze data generated from every medical device manufactured and marketed.

An eQMS, such as SimplerQMS, with in-built complaint management capabilities, can make the process easier.

For example, using SimplerQMS, companies can report incidents to regulatory authorities in case the nonconformance presents a potential risk to patients or results in injury or death.

MDSAP Key Considerations

Medical device companies planning on undergoing the MDSAP should note the following points:

• Audit duration: The audit cycle of MDSAP has three years. It consists of an Initial Audit (in two separate stages), two Surveillance audits in the next two years, and a Recertification Audit in the third year.
• Audit requirements: Since MDSAP is a comprehensive audit program involving multiple inspectors, companies should be well-prepared with trained personnel. They should be available to answer the inspectors’ queries and provide the required documents and records.
• Resources: MDSAP audits have a cost for medical device companies to be certified. Companies must have the appropriate resources.
• Documentation and record keeping: There is a need to have a robust QMS with efficient documentation and record-keeping implemented.

Traditional paper-based or hybrid QMS can present challenges, such as lost documents, delays in document management activities, lack of traceability, etc.

So, it is important to consider transitioning to an eQMS. SimplerQMS solution facilitates efficient document management. You can store all records securely in one place, easily search and retrieve documents, assign tasks, automatically notify personnel, and so on.

Frequently Asked Questions

What is the Difference Between ISO 13485:2016 and MDSAP?

The difference between ISO 13485:2016 and MDSAP is that ISO 13485:2016 is an international quality standard, and MDSAP is an audit program.

Furthermore, ISO 13485:2016 is a regulatory medical device QMS standard utilized worldwide. On the other hand, MDSAP is currently conducted in five countries: Australia, Brazil, Canada, Japan, and the United States.

Does FDA Recognize MDSAP?

The US Food and Drug Administration (FDA) is one of the participating members of the MDSAP. It accepts MDSAP audit reports as a substitute for FDA Establishment Inspection Reports (EIR) for on-site inspections.

Is the EU Part of MDSAP?

The European Union (EU) is an official observer of MDSAP and may attend MDSAP meetings, assessments, and other activities. However, MDSAP is not accepted in the EU to replace or supplement its regulatory scheme.

Who Can Perform MDSAP Audits?

MDSAP audits are performed by Auditing Organizations (AOs). These organizations are authorized by the participating Regulatory Authorities to audit under MDSAP requirements. Medical device manufacturers that wish to be MDSAP certified must refer to their national AO list.

Is MDSAP a Certification?

The MDSAP provides a certification that allows a medical device manufacturer’s QMS to be audited using a single audit and accepted in five countries: Australia, Brazil, Canada, Japan, and the United States.

What are the Principles of MDSAP?

MDSAP is based on ISO 13485:2016 requirements. In addition, medical device manufacturers must comply with specific country regulatory requirements for Australia, Brazil, Canada, Japan, and the United States, depending on the intended market.

What Processes Include the MDSAP Audit Scope?

The MDSAP audit scope has a total of seven processes.

There are four primary processes: Management Process, Measurement, Analysis, and Improvement; Design and Development; and Production and Service Controls.

One enabling process: Purchasing.

And there are two additional supporting processes: Medical Device Adverse Events and Advisory Notices Reporting and Device Marketing Authorization and Facility Registration.

The Role of eQMS Software in Preparation for MDSAP

The Medical Device Single Audit Program is a unique opportunity for medical device manufacturers to access up to five international markets with a single QMS audit.

However, medical device companies do need to extensively prepare for a comprehensive, time-consuming, and expensive audit keeping in mind the requirements of multiple jurisdictions.

When using paper-based or hybrid QMS systems, challenges may arise in the form of lost documents and records, physical storage issues, unauthorized access to files, human errors, and so on.

Considering that an MDSAP audit requires extremely meticulous documentation and record-keeping, a purpose-built medical device eQMS solution can be an excellent asset for any medical device company.

An eQMS provides traceability of documents, time-stamped audit trails, automated notifications, liking documents, assigning tasks, and so on.

Best QMS software solutions for life sciences support a vast array of core QMS processes, such as document control, change management, training management, complaint handling, supplier management, and CAPA management, that are closely related to processes evaluated during MDSAP audits.

So, investing in a robust and powerful medical device eQMS, such as SimplerQMS, can make the challenging path of preparing for an MDSAP audit much smoother and simpler.

If you are interested in calculating the investment of a QMS software solution, download our eQMS Business Case Template. It will help you understand the cost of such a solution and provide the tools to present it to senior stakeholders and decision-makers.

Final Thoughts

The medical device industry is highly regulated. Companies must comply with multiple regulatory requirements to legally market and sell their devices in different countries.

To be certified according to these requirements, medical device companies must undergo third-party audits, which can be time-consuming and expensive.

Aiming to conduct a single regulatory audit of a medical device manufacturer’s QMS that satisfies the requirements of multiple regulatory jurisdictions, the Medical Device Single Audit Program was created. It has five participating members: Australia, Brazil, Canada, Japan, and the United States.

The MDSAP is a way that medical device companies can be audited once for compliance with the standard and regulatory requirements of these five different markets.

During audits, having a paper-based or hybrid QMS can present challenges, such as lost documents, human errors, physical storage limitations, unauthorized access to documents, and so on.

An eQMS offers a solution to all those issues. And SimplerQMS Software helps medical device manufacturers to streamline all audit-related activities. You can create documents using a template package based on Medical Device requirements, link relevant documents, directly escalate nonconformances to CAPA, set up automatic reminders for tasks’ due dates, and more.

Book a personalized demo and talk to our experts if you want to learn more about how SimplerQMS can support your company QMS.

The post MDSAP: Medical Device Single Audit Program appeared first on SimplerQMS.

Manufacturers of medical and in vitro diagnostic devices that wish to be part of the European Economic Area market must adhere to regulatory requirements to ensure their products meet quality and safety standards.

Legislation and international standards regarding medical devices, such as EU MDR 2017/745 and ISO 13485:2016, can be complex to follow but is essential to life science organizations’ success. Not following these regulations and standards can lead to manufacturers stopping their production altogether.

In this article, we will learn about the principal regulations for obtaining CE marking, followed by a step-by-step guide to getting a medical device’s CE marking. We will also visit some of the most common questions regarding this matter and see how an Electronic Quality Management System (eQMS) can help you streamline the process to have a declaration of conformity.

One of the best ways to streamline your processes to obtain a CE marking nowadays is to use eQMS software. SimplerQMS offers a cloud-based eQMS for medical devices that supports regulatory compliance, audit process, document control, all the technical documentation you will need, and much more. Book a demo with one of our quality solution experts and be a step closer to your CE marking!

We will cover the following topics:

• What Is CE Marking for Medical Devices?
• Why Is CE Marking Important?
• Relevant Standards and Regulations
• How To Obtain CE Marking for Medical Devices?
• SimplerQMS Streamlines CE Marking Process
• Frequently Asked Questions About CE Marking

What Is CE Marking for Medical Devices?

CE marking means Conformité Européenne or European conformity in French. And as the name suggests, it proves product compliance with European requirements that ensure specific safety, health, and environmental protection standards.

It can be required for several different products. Regarding medical devices, the CE marking allows companies to move and sell their devices across the 30 countries of the European Economic Area (EEA) once they follow the EU Regulation 2017/746, also known as Medical Device Regulation (MDR).

The MDR is the European regulation concerning placing medical devices and accessories on the market for human use.

Another similar legislation is EU 2017/746 for in vitro diagnostic devices, referred to as In Vitro Diagnostic Regulation or IVDR. However, IVDR is not the aim of this article.

So, to summarize, the letters ‘CE’ on medical devices represents a product that meets all legal requirements to be traded throughout the EEA. Manufacturers know their devices can be sold and marketed legally, and patients benefit from a safe device.

Why Is CE Marking Important?

All medical devices that comply with European legislation can obtain a CE marking.

A product cannot be legally sold and marketed in EEA countries without it. Devices used exclusively for research are the only exception and can enter these countries.

Complying with this regulation brings opportunities for many companies worldwide to expand their business.

CE marking indicates that the medical device went through risk assessment processes and is a safe and high-quality product for the patient.

For instance, during the COVID-19 pandemic, lots of infrared thermometers were placed on the European market. Regardless of the manufacturer’s country of origin, the CE marking indicates that these devices comply with requirements and can be legally sold and marketed in the EEA countries.

Let’s see some of the key benefits of having a CE marking:

• Indicates that your device complies with essential EU legal requirements.
• Allows commercialization in all 30 member countries of the EEA.
• Some countries outside EEA accept CE marking, which is an advantage when entering other new markets.
• Indicates your device meets safety and quality regulations and standards.

An essential step for obtaining a CE marking is to implement a Quality Management System (QMS). Implementing a medical device eQMS software is a smart decision that has been helping several manufacturers to comply with the MDR and IVDR.

Over the last decade, an increasing number of companies of all sizes have been migrating from paper-based or hybrid QMS systems to specific QMS software solutions.

SimplerQMS is one such solution, providing an end-to-end quality management software that helps medical device and other Life Science companies streamline their quality processes, speed up time to market, and improve compliance with international standards and regulations such as ISO 13485 and MDR.

Relevant Standards and Regulations

It is essential to know the regulations and standards involved in medical devices. We will break down the most important international standards and regulations you need to know to understand better how the CE marking process works.

Regulation (EU) 2017/745

The regulation EU 2017/745, also referred to as the Medical Devices Regulation or MDR, is the current regulation that replaces the previous Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMD) entirely.

The regulation describes all the mandatory procedures, transition arrangements, and explanations. If you are a medical device manufacturer, please always refer to this regulation for accurate information.

Although it was published in 2017, the requirements for placing medical devices on the European market only took effect on 26 May 2021.

According to MDR, transition arrangements allow some devices already on the market with MDD to remain available until 27 May 2025. 

However, as we write this article, the European Commission proposes a deadline extension postponing the MDR deadline of 26 May 2024 until 2027 for Class III and IIb devices and May 2028 for Class IIa and I devices.

Directive 2001/83/EC

Directive 2001/83/EC is related to placing medicinal products for human use on the market.

When medical devices are combined with a medicinal product, such as a drug, manufacturers need to determine which part of the combined product is responsible for its main activity.

If the drug helps improve the medical device’s activity and cannot be used alone, it becomes an integral part of the device. The combined product is considered a medical device and must be in accordance with EU 2017/745.

Regulation (EC) 276/2004

Regulation EC 276/2004 is related to placing medicinal products for humans and veterinary use on the market.

Regarding medical devices, it works the same way as Directive 2001/83/EC.

Directive 2004/23/EC

The directive 2004/23/EC sets quality and safety standards for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells.

Medical devices containing non-viable tissues or cells with a secondary activity must comply with MDR.

EU MDR’s general safety and performance requirements must apply to the part of the device containing those elements, regardless of their main activity.

ISO 13485:2016

Medical devices — Quality management systems — Requirements for regulatory purposes.

The ISO 13485:2016 standard outlines the requirements of a QMS for medical devices.

Manufacturers of medical devices usually adhere to this standard since following it presumes compliance with QMS requirements presented in the MDR.

Following this standard indicates compliance with QMS requirements, such as:

• Quality Manual
• Document and Record control
• Quality management system
• Human resources
• Manufacturers infrastructure
• Contamination control
• Design and development planning, verification, validation, transfer, changes, and files of medical devices
• Evaluation and selection of suppliers
• Servicing activities
• Requirements for sterile medical devices
• Identification and traceability of medical devices
• Complaint handling
• Control of nonconforming products
• Post-market surveillance

ISO 14971:2019

Medical devices — Application of risk management to medical devices.

ISO 14971:2019 was developed specifically for medical device manufacturers based on established risk management principles and can be used as guidance in developing and maintaining processes.

Risk management is a requirement of MDR. However, manufacturers can achieve compliance without the need to be certified by this ISO.

FDA 21 CRF Part 820

The FDA 21 CRF Part 820 establishes quality system requirements applicable to medical device manufacturers. It is the current regulation of QMS for medical devices used in the United States.

Medical device companies targeting the US market must have a QMS compliant with FDA 21 CFR Part 820 and FDA clearance.

This code of regulation can serve as a guideline for the QMS requirement of MDR in the European market. However, most companies choose to follow ISO 13485:2016 standard, since it can be certified.

How To Obtain CE Marking for Medical Devices?

Obtaining a CE marking can be rather complex, so to assist you, this guide will outline the general steps of this process.

Keep in mind that this guide is for educational purposes. For complete information, medical device manufacturers should always refer to the MDR.

Many companies hire consulting firms to manage CE marking processes in parts or whole. However, due to the recent MDR implementation, these professionals are in high demand, so it can be difficult to get a hold of them.

The process of placing a medical device on the market generates a high volume of documents. An eQMS can help manufacturers manage all this data accurately, facilitating compliance with QMS requirements in MDR.

To ensure documentation is already being created following requirements, having a Medical Device Quality Management System in place is a good start.

SimplerQMS supports compliance with all the requirements mentioned above by providing a fully validated eQMS that helps companies manage quality throughout the product life cycle. In the following sections, we will showcase a few more examples of how an eQMS can help streamline some of the processes needed to obtain a CE marking.

Let’s see a brief overview of the steps before going further:

1. Determine Your Medical Device Classification
2. Designate a Person Responsible for Regulatory Compliance
3. Implement a Quality and Risk Management System
4. Prepare Technical Documentation
5. Implement Supplier Management System
6. Conduct a Clinical Evaluation
7. Assign a European-Authorized Representative (if Applicable)
8. Obtain Certification by a Notified Body
9. Prepare a Declaration of Conformity
10. Register Your Device Under a Unique Device Identifier
11. Affix a CE Marking to the Medical Device
12. Maintain a Post-Market Surveillance

1. Determine Your Medical Device Classification

The MDR established rules to classify medical devices according to the risk level, placement on the body, and duration of use.

We will cover them briefly in this article, but you can read our EU MDR medical device classification guide for more detailed information.

Risk

Devices are divided into classes I, IIa, IIb, and III.

The higher the classification, the higher the risk the device represents to the patient.

Body Placement

Devices can be non-invasive when they are on the body’s surface and invasive when they penetrate inside the body.

There are also active devices that depend on a source of energy other than that generated by the human body.

Duration of Use

The duration of use is also gradual, being a transient use of up to 60 minutes, a short-term use of up to 30 days, and above that period, it becomes a long-term use device.

The regulation also brings 22 rules to help manufacturers correctly classify their devices. Those rules specify the class of a device based on its application and how this class can vary depending on body placement, duration of use, and increased risk to the patient.

2. Designate a Person Responsible for Regulatory Compliance

Medical device manufacturers must have at least one person responsible for regulatory compliance within the company. And this person needs to have expertise in the field of medical devices.

If you are still a small organization, there is no need to have personnel on-site. But this person has to be available permanently and continuously.

3. Implement a Quality and Risk Management System

The MDR requires manufacturers to have quality and risk management systems.

That is why medical device companies chose to comply with ISO 13485:2016 because it is presumed to be in conformity with MDR requirements regarding QMS.

These days, leading companies are choosing to implement electronic QMS over the traditional paper-based or hybrid system. Digital systems simplify QMS documentation and streamline audits.

A QMS software solution like SimplerQMS can streamline and automate many aspects of quality management, from document control and change management to training, audits, suppliers, non-conformances, CAPAs, and more.

4. Prepare Technical Documentation

Technical documentation, also known as medical device technical files, contains detailed information regarding your medical device lifecycle and is a requirement of MDR.

A crucial process is the Design Control or Design Dossier, which contains information about a device’s physical characteristics and construction. It must prove that the medical device was designed in the best way possible to minimize the risk of injuries or accidents.

To achieve compliance, all documentation needs to be well organized, readily accessible, and easy to understand.

It includes, but is not limited to:

• Device description and specification
• Description of the accessories and variations
• Reference to previous and similar generations
• Instructions in the country’s language in which the device will be sold
• Design and manufacturing information
• Information for the demonstration of conformity with the general safety and performance requirements
• Risk analysis documents, such as design risk, production risk, biological risk, and so on
• Product verification and validation
• Post-market surveillance plan

These documents must be retained for a period of 10 to 15 years, depending on the device classification and customer requirements.

SimplerQMS helps with the compilation of Technical Documentation. Using our robust design controls and cloud-based storage, medical device manufacturers have the support to achieve compliance with the MDR.

5. Implement Supplier Management System

MDR requires medical device companies to have supplier management. Suppliers must be audited to ensure compliance with requirements and conformity.

It is helpful to create a list of approved suppliers based on predetermined criteria to ensure only qualified suppliers provide products and services.

In accordance with the MDR, medical device manufacturers’ suppliers can, if needed, be audited by external organizations, known as Notified Bodies. The audits can be announced or unannounced.

The supplier audit can be simplified if they have already been audited by a Notified Body or have a certified QMS.

SimplerQMS solution assists you with your supplier management processes by providing a centralized repository for all your supplier information, maintaining an Approved Supplier List (ASL), creating an audit plan, as well as other reoccurring supplier-related tasks, and receiving notifications when scheduled tasks are due.

6. Conduct a Clinical Evaluation

Manufacturers must conduct a clinical evaluation to demonstrate conformity with safety and performance requirements.

Practically, it means a plan to collect and analyze clinical data from relevant scientific literature and clinical investigations involving the specific medical device or an equivalent product.

Manufacturers must also consult an expert panel for devices in classes IIb and III.

7. Assign a European-Authorized Representative (if Applicable)

If a medical device manufacturer is not based on the EEA, they will need to appoint an authorized representative inside the member countries.

The authorized representative is responsible for actions such as:

• Verifying the technical documentation
• Informing the manufacturer about complaints
• Registering a physical place for the Notified Body to receive samples of the device for inspection

Imagine a medical device manufacturer from Canada who wishes to enter the EU market to sell pacemakers. To do so, they will need a European representative to address their documentation inside Europe.

8. Obtain Certification by a Notified Body

Notified Body is an independent organization designed to assess the conformity of specific products before their placement on the market.

Regarding medical devices, they are responsible for auditing and certifying manufacturers concerning the conformity of devices with MDR.

A list of valid Notified Bodies can be found in the New Approach Notified and Designated Organizations (NANDO) system.

A Notified Body does not need to assess manufacturers of class I non-sterile and no measuring devices. In these cases, companies can issue a self-declaration of conformity.

For higher classes devices, this certification is mandatory, specific for each procedure, and has a maximum validity of five years.

The Notified Body will then audit the manufacturer’s QMS and technical documentation to verify conformity with the MDR. This is a critical part of the process.

Manufacturers will receive a certification from the Notified Body once the audit is complete. In the case of audit findings, those must be corrected and closed before another audit round is conducted.

Audits and assessments occur periodically every year to ensure companies are applying the approved QMS and post-market surveillance plan.

9. Prepare a Declaration of Conformity

After being certificated by a Notified Body, manufacturers must draw up a Declaration of Conformity, assuming responsibility that the requirements specified in MDR have been fulfilled.

10. Register Your Device Under a Unique Device Identifier

To facilitate the traceability of medical devices, a unique device identifier (UDI) needs to be assigned individually to specific device models.

The UDI is a unique number or alphanumeric code stored in the European Database on Medical Devices (EUDAMED), where crucial information about the device can be found.

Affixing the UDI is an additional requirement. And it does not replace the CE marking or other labeling requirements.

11. Affix a CE Marking to the Medical Device

After being approved by national authorities and certified by the Notified Body, manufacturers can place the CE marking on their medical devices.

The CE marking must be affixed to the device itself, in the packaging, and on any instructions for use.

It is crucial for the CE marking to be visible, legible, and made with a material that cannot be washed away.

For medical devices class II and III, the four-digit number of the Notified Body also needs to be printed alongside the CE marking.

12. Maintain a Post-Market Surveillance

Before obtaining a CE marking and placing a medical device into the EAA market, manufacturers need to demonstrate that a post-market surveillance system is already in place to address questions on safety and effectiveness.

Medical device companies must collect data regarding their marketed devices through post-market surveillance, vigilance, and market surveillance plans.

This feedback involves continuously evaluating the patient’s experience with the medical device and the product life cycle.

Requirements of manufacturers are:

• Follow-up complaints, adverse events, and non-conformity cases
• Update safety reports periodically
• Perform internal audits and supplier audits routinely
• Keep technical documentation, databases, and registers updated

This surveillance ensures proactive action to collect and review device quality and safety information from real-world evidence. Therefore, manufacturers can better address customer complaints, identify risks, and implement recalls and other market actions.

For more details, you can also read your article about Post-Market Surveillance (PMS) for medical devices.

A smart way to handle your device PMS is by implementing an eQMS with features such as built-in forms for handling non-conformance and complaint events that allow for automated linking and processing of Corrective and Preventive Actions (CAPAs).

SimplerQMS software offers all of that and more. Medical device companies can easily link any PMS issue to a specific device, component batch, customer complaint, and equipment failure.

SimplerQMS Streamlines CE Marking Process

There are many steps to obtain the CE marking, and there is even more documentation for each step.

Managing these documents is challenging enough, and more so with a paper-based QMS. Even with a hybrid system, important documents can be lost, filled in wrongly, and taken too long to access during an audit.

Storage is also an issue when using physical files. Keeping a significant number of documents for up to 15 years or even more can be troublesome space-wise.

Here are some exciting features medical device eQMS, such as SimplerQMS, offers:

• QMS software facilitates the process of compiling technical documentation by keeping all relevant information in one location and making it easy to share and access.
• Allows the development of documents using best-practice ISO 13485:2016 templates and forms.
• Automates various documentation processes, freeing your team to focus on more critical tasks and saving time while ensuring consistency and accuracy of information.
• Simplifies the auditing process, as the system ensures accurate and readily available documents in a cloud storage system.
• Helps maintain your CE marking of conformity, as it already has post-market surveillance plans and processes to deal with complaints and adverse events.
• Helps you keep the documentation organized for as long as required for your medical devices without compromising physical space.

With the MDR in place, transitioning can be much easier using an eQMS solution.

SimplerQMS provides a cloud-based quality management software built to help medical device companies comply with Life Science requirements and obtain their CE marking.

The software solution automates and facilitates your quality management processes, saving valuable time and resources while helping you ensure compliance.

We provide a fully validated system according to GAMP 5 and conduct continuous re-validation, so there is no need to spend time and money on validation yourself. SimplerQMS takes full responsibility for our solution and provides audit assistance related to eQMS software.

If you are interested in implementing an eQMS solution in your company, go ahead and download our eQMS Business Case template. With this, you can calculate the real economic benefit and time advantages of an eQMS versus a manual or paper-based system!

Frequently Asked Questions About CE Marking

Is CE Marking the Same as FDA Approval?

European CE marking and United States FDA approval both have the same goal – to assess the safety and efficacy of medical devices. However, they are only valid in the markets on which they are based.

Which Countries Require CE Marking for Medical Devices?

CE marking is required in the countries of the European Economic Area, which encloses the EU countries as well as Iceland, Norway, Lichtenstein, and Switzerland.

How Long Does CE Marking Approval Take?

CE marking approval times are variable. It depends on the class and complexity of the device, as well as whether the manufacturer has a QMS in place and is already ISO 13485:2016 certified. Usually, obtaining a CE marking can take 16 to 18 months from beginning to end.

How Long Is a CE Marking Valid?

CE marking validity will be determined by the Notified Body and depends on the medical device classification, but it cannot exceed five years. After that, the device needs to be re-certificated.

For instance, a class IIa device can receive a certificate valid for just three years.

Moreover, annual surveillance audits are conducted between certifications.

Can I CE Mark My Own Medical Device Product?

Medical devices class I non-sterile and no measuring types can be self-declared. However, higher classes need to be assessed by Notified Bodies to receive a CE marking.

How Many Notified Bodies Are There For the CE Marking?

According to the NANDO database, in the year 2022, 34 Notified Bodies are authorized for MDR and 7 for IVDR.

Is CE Marking the Same As UKCA Marking?

Both CE marking and UKCA marking share the same goal – to ensure the safety and quality of products. But CE marking is specific to the EEA market, and UKCA marking is exclusive for products placed in Great Britain (England, Scotland, and Wales).

Final Thoughts

Obtaining a CE marking is a mandatory step for medical device manufacturers that intend to sell their products on the EEA market.

This can be a somewhat complex process involving a high volume of technical documents that must be accurate and in compliance with standards and regulations.

Thus, having QMS software in place is a smart decision to manage all information about medical devices successfully.

SimplerQMS provides a QMS software solution that supports compliance with MDR and ISO 13485:2016 and helps medical device organizations of all sizes streamline their CE marking process.

If you are interested in streamlining quality management processes and making compliance simpler for your business, book a demo and talk to our experts today!

The post CE Marking for Medical Devices [Step-by-Step Guide] appeared first on SimplerQMS.

As per current international regulatory guidelines, your medical device company must maintain DHRs (or similar records) for every batch, lot, or unit of a given medical device.

Device History Records allow your company and internal and external stakeholders to identify any potential deviations in the medical devices that you manufacture. Additionally, a DHR is an essential component of the company’s Device Master Record (DMR)/Medical Device File (MDF), which contains all information pertaining to the manufacture of each medical device by your company.

In this article, we will delve into the details of a Device History Record (DHR), the importance of well-documented Device History Records, the contents of a DHR, and electronic device history record management.

But first, let us understand the basics.

• What is a Device History Record (DHR)?
• Key Regulatory Requirements for Device History Records
• Why Are Well-Documented Device History Records So Important?
• What Must a Device History Record (DHR) Include?
• The Role of a Device History Record (DHR) in Quality Management
• Electronic Device History Record (eDHR) Management

What is a Device History Record (DHR)?

Device History Records contain the complete history of every medical device that your medical devices company manufactures. Essentially, each Device History Record should contain complete documentation concerning the manufacture and tracking of each medical device that your company markets.

Current international regulatory standards, including the US FDA 21 CFR Part 820.184 and ISO 13485.2016, state that your medical devices company should maintain Device History Records (or similar records) for every lot, unit, or batch of medical devices.

When a DHR pertains to a particular lot of a medical device, it can also be termed a Lot History Record. By definition, a Lot History Record is the document that authorizes and controls the production of a single lot of components or finished medical devices.

For example, all records about a particular lot of IV catheters that are manufactured in one of your plants will constitute a Lot History Record.

Key Regulatory Requirements for Device History Records

For medical device organizations wanting to sell their products in the US market, FDA 21 CFR Part 820.184 is applicable.

It details Device History Record requirements that your company must maintain.

For medical device companies wanting to sell their products in the European Union market, ISO 13485:2016 regulations will apply.

Since there is no specific requirement mentioned for a “Device History Record”, section 7.1 (Planning Product Realization) highlights that every medical device organization must plan and develop all the required processes for product realization. These processes must be consistent with other requirements of a medical device QMS.

Nowadays, more and more medical device companies, small and large, start-ups, and established ones opt for a modern eQMS to avoid the hassle of maintaining all records and documents using traditional paper-based or hybrid systems.

An eQMS helps medical device companies to manage Device History Records (DHRs) and other quality-related documents electronically in a tamper-proof, audit-friendly manner.

Medical Device QMS software by SimplerQMS provides medical device companies of all sizes with powerful, built-in document control capabilities that ensure that all records and documents are readily retrievable, secure, and never lost or misplaced.

Why Are Well-Documented Device History Records So Important?

You must maintain separate Device History Records for all your medical devices. Not only is a Device History Record (DHR) an essential regulatory requirement, but it also provides all details about a given medical device.

When a DHR is well-documented, it will provide you with the required evidence if any quality issues do crop up.

A Device History Record that you create for a particular medical device should be maintained during the entirety of the lifecycle of that product. At times, it may need to be maintained for longer durations depending on the specific requirements applicable to your medical device company.

Let us take a closer look at the importance of a Device History Record (DHR):

• Device History Record will help ensure compliance by providing auditors with evidence that a given medical device has been manufactured, controlled, and approved following industry-validated standards and specifications.
• Device History Record helps increase efficiency in case there is a customer complaint. The ensuing investigation and root cause analysis will be based on the details stored in a DHR.
• Device History Records are essential for producing higher-quality products. Since Device History Records are a collaborative effort between several departments within the company, you are assured that the best efforts are put in to produce higher quality products.
• Well-documented Device History Records will save your company money and reduce liabilities. You can easily demonstrate that all batches of a given product have been manufactured and tested following industry standards.

A well-documented Device History Record provides you and external stakeholders with irrefutable evidence about all the steps involved in the manufacture of a given product.

In the absence of a well-documented DHR, it would be next to impossible for your company to diagnose the root cause of non-conformances. If you cannot do the correct diagnosis, how will you correct the non-conformance? How will you prevent it from recurring?

Furthermore, the importance of a digital QMS solution such as SimplerQMS becomes even more pronounced in light of the fact that a Device History Record is constantly evolving, and the amount of documentation required for medical device manufacturers is only going to increase in the future.

We will touch on more specific examples and the role played by a well-documented Device History Record in quality management, as well as the benefits of going digital, in just a moment.

First, let us see the contents of a Device History Record (DHR).

What Must a Device History Record (DHR) Include?

There are two key regulatory guidelines that your company will have to follow concerning the documentation requirements for Device History Records. The regulatory requirements depend on where you want to sell your medical devices, the USA, European Union, or both.

FDA 21 CFR Part 820.184 states the following:

Each manufacturer shall maintain device history records (DHR’s). Each manufacturer shall establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:

a) The dates of manufacture;

b) The quantity manufactured;

c) The quantity released for distribution;

d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;

e) The primary identification label and labeling used for each production unit; and

f) Any unique device identifier (UDI) or Universal Product Code (UPC), and any other device identification(s) and control number(s) used.

ISO 13485: 2016 Section 7.1 explains the following:

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system.

The organization shall document one or more processes for risk management in product realization. Records of risk management activities shall be maintained.

In planning product realization, the organization shall determine the following, as appropriate:

a) quality objectives and requirements for the product;

b) the need to establish processes and documents and to provide resources specific to the product, including infrastructure and work environment;

c) required verification, validation, monitoring, measurement, inspection and test, handling, storage, distribution and traceability activities specific to the product together with the criteria for product acceptance;

d) records needed to provide evidence that the realization processes and resulting product meet requirements.

The output of this planning shall be documented in a form suitable for the organization’s method of operations.

In summary, the requirements mentioned above emphasize that manufacturers of medical devices must maintain Device History Records or similar records for each lot, batch, and unit of every medical device.

Amongst other things, they must contain details of the date of manufacture, quantity manufactured and released, and a Unique Device Identifier/Universal Product Code. All the records that are maintained should provide evidence that the processes used, and the products manufactured are following specifications.

The example given below gives a fair idea of what should a DHR include.

Note. This is based on the provisions of FDA 21 CFR Part 820.184.

1. Device History Record creation: The creation of a particular DHR (either lot/unit/batch) will be based on your company’s Device Master Record (DMR) or Medical Device File (MDF). Device Master Record will contain all the information that you require for manufacturing a given product. The Medical Device File will contain descriptions of all design records, manufacturing processes, QMS criteria, and so on.
2. The dates of manufacture: The details of the dates on which particular lots/units/batches of a given medical device were manufactured.
3. The quantity manufactured: All the details of the quantity manufactured in accordance with a particular batch, lot, or unit of a medical device.
4. The quantity released for distribution: Here, you will need to include details of all the quantities that have been released for distribution, based on the batch, lot, or unit of a given medical device.
5. Acceptance/inspection records: The details herein will demonstrate to your stakeholders that a given medical device has been manufactured in accordance with the DMR/MDF, the details of which are given in point 1.
6. Unique identification number: Here your company will mention a unique device identifier (UDI), or a universal product code (UPC); you may use any other device identification methodology specific to your products.
7. Primary identification label: This is the labeling that your company uses for each production unit.

SimplerQMS allows you to maintain Device History Records electronically as well as link them between other related documents, such as results of acceptance/inspection testing reports within your Device History Record (DHR). With all this information in a central location, you can easily retrieve Device History Records when needed – during an audit, for example – and have complete confidence that your Device History Records are up to date.

The Role of a Device History Record (DHR) in Quality Management

As mentioned earlier, we will now look at specific examples and the roles played by a well-documented Device History Record in Quality Management System.

DHR for More Successful Audits

When your medical device company maintains a well-documented Device History Record, it becomes a lifesaver during medical device audits.

The reason is auditors will most likely choose a particular lot from your manufactured devices and will then appraise all related activities. For example, whether the product is compliant with your internal protocols, Device Master Record (DMR), Medical Device File (MDF), and external requirements.

Your Device History Record is crucial for validating these points.

With medical device QMS software with built-in audit management capabilities like SimplerQMS, the entire auditing process is made even more efficient. The audit management software module will help your company reduce both time and effort by completely automating audit-related activities, including data collection, routing, notifications, follow-ups, approvals, and escalation of activities, when required. Plus, centralized storage and easy retrieval of the records make the entire process much smoother.

DHR for Assisting CAPA Investigations

Whenever a customer complaint or nonconformance issue is submitted, or even after reporting an audit finding, your CAPA team will be able to get to the root cause of the problem by checking a Device History Record for the product identifier. Using these details, they can isolate the problematic lot or batch, and also check whether the problem is affecting one or all batches.

For example, a hospital that has received a batch of programmable pacemakers raises a complaint that one or more devices are malfunctioning. With the help of a Device History Record, the CAPA management team will be able to pinpoint whether it is only that particular batch that is causing problems.

Furthermore, by using an eQMS with a built-in CAPA management solution, the process of identifying, uncovering, resolving, and reporting all CAPAs becomes much more streamlined. The built-in dashboards help you in analyzing data, identify patterns, and give a better understanding of the impact of every complaint, deviation/non-conformance.

DHR for Promoting Continuous Process Improvement

A well-documented DHR will be very beneficial in promoting continuous process improvement.

For example, a batch of programmable pacemakers has been dispatched after passing the acceptance criteria. However, the hospital that received this batch complained of more than one non-conforming pacemaker.

Device History Record will help your team trace back the non-conformance to a specific batch. This will help you get a better understanding of the problem and, therefore, revamp the acceptance criteria.

This will ensure that future defects do not repeat.

DHR for Saving Costs

Device History Record will help your company in executing targeted recalls.

Let’s imagine that you have received 5 nonconformance complaints out of 50 batches of programmable pacemakers that have been distributed. Analysis of a Device History Record shows that the 5 complaints are all from a single batch. This information helps you in executing a targeted recall of that batch, rather than having to recall all 50 batches of pacemakers.

If you have traditional paper-based documentation systems, analyzing the data becomes cumbersome. With SimplerQMS’s QMS software solution, you will easily update a Device History Record for every new batch of medical devices that you release in the market. This helps you easily find a batch in case a recall is necessary.

DHR for Streamlined Liability Management

Similar to the above example wherein a well-documented Device History Record helps you in targeted recalls, it also allows your company to accurately trace and recall faulty medical devices from the market.

This is crucial to reducing your liability.

For example, complaints about faulty programmable pacemakers have come from several sources. With the assistance of a DHR, you will be able to identify and recall all such faulty devices.

DHR for Investigative Purposes

With a well-documented Device History Record, you will know the precise quantities of each medical device manufactured and distributed by your company.

For example, several programmable pacemakers have gone missing from one of your plants. A Device History Record will help you provide precise information to the investigative authorities about the exact numbers missing.

Electronic Device History Record (eDHR) Management

A Device History Record is a living document. Living documents (evergreen documents/dynamic documents) are continually edited and updated. Similarly, a DHR must be revised with every new batch, lot, or unit of a given medical device.

If you are continuing to use traditional manual-based documentation systems or even a hybrid system, you are more than likely to face a few challenges. You may not get the correct information from each manufacturing plant about the exact number of different devices that have been produced. Important documents may get lost, deleted, or stolen. You may find it exceedingly difficult to manually link Device History Records to other documents. Lastly, producing paper records during an inspection is not acceptable.

You can easily bypass or eliminate the above-mentioned challenges when the company invests in a medical device eQMS software solution, like SimplerQMS, that has robust inbuilt document controls.

The SimplerQMS software solution ensures that only authorized personnel have access to approved documents. Such access rights are controllable by role, site, project, and department. The automated workflows in the software solution make certain that only authorized personnel are notified on being assigned tasks such as document review and approval. Another key benefit is that you are assured of compliance with all the relevant standards and regulations applicable to medical device companies.

With SimplerQMS you will be able to seamlessly integrate electronic Device History Records with other related digital quality sub-systems including CAPA, nonconformance, audit, complaint management systems, and many others. This will advance efficiency and compliance with international standards and regulations across the entire organization.

Final Thoughts

Device History Records include all the information pertaining to the manufacture and distribution of every medical device that your company markets.

Traditional manual-based or hybrid documentation and record management systems can impose challenges on the company. To avoid/eliminate these problems, you can invest in an efficient software solution such as quality management software by SimplerQMS.

Book a demo today and talk to a SimplerQMS system expert if you are keen on streamlining your Device History Record management processes while assuring compliance with the applicable regulatory requirements.

The post What is a Device History Record (DHR) and Why is it Important? appeared first on SimplerQMS.