What is EU IVDR? A Detailed Introduction (and Role of eQMS)
The European Union In Vitro Diagnostic Regulation (EU IVDR) is the European law concerning placing...
How GMP Compliance Is Reflected in QMS (Role of eQMS)
Good Manufacturing Practices (GMP) is a part of the Quality Management System that helps ensure...
10 Benefits of a Quality Management System (QMS)
The benefits of a Quality Management System (QMS) are numerous and wide-ranging. A QMS will help...
MDSAP: Medical Device Single Audit Program
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single...
What is ISO 15189? A Detailed Introduction (and Role of eQMS)
The ISO 15189:2022 is an international standard that specifies the requirements for quality and...
![ISO 13485:2016 Compliant QMS [Role of an eQMS]](svg/integrated-iso-13485-qms-illustration.svg)
![ISO 13485:2016 Compliant QMS [Role of an eQMS]](https://www.simplerqms.com/wp-content/uploads/2022/10/integrated-iso-13485-qms-illustration.svg)
ISO 13485:2016 Compliant QMS [Role of an eQMS]
The ISO 13485:2016 is an international regulatory standard that specifies the requirements for...
![CE Marking for Medical Devices [Step-by-Step Guide]](svg/ce-marking-eu-illustration.svg)
![CE Marking for Medical Devices [Step-by-Step Guide]](https://www.simplerqms.com/wp-content/uploads/2022/11/ce-marking-eu-illustration.svg)
CE Marking for Medical Devices [Step-by-Step Guide]
To sell and market your medical device across the European Union (EU), you must have a CE marking...
![21 CFR Part 820 Quality System Regulation [Role of an eQMS]](svg/fda-21-cfr-part-820-quality-system.svg)
![21 CFR Part 820 Quality System Regulation [Role of an eQMS]](https://www.simplerqms.com/wp-content/uploads/2022/11/fda-21-cfr-part-820-quality-system.svg)
21 CFR Part 820 Quality System Regulation [Role of an eQMS]
Let’s imagine that your medical device company, headquartered in Nurnberg, Germany, has designed...
![Vendor Management Process in Clinical Research [How-To Guide]](svg/clinical-vendor-oversight.svg)
![Vendor Management Process in Clinical Research [How-To Guide]](https://www.simplerqms.com/wp-content/uploads/2022/11/clinical-vendor-oversight.svg)
Vendor Management Process in Clinical Research [How-To Guide]
Imagine yourself in the shoes of a lead clinical investigator or a seasoned product manager...
![EU MDR Quality Management System [Role of an eQMS]](svg/eu-mdr-qms-icon.svg){kind=icon}
![EU MDR Quality Management System [Role of an eQMS]](https://www.simplerqms.com/wp-content/uploads/2022/11/eu-mdr-qms-icon.svg){kind=icon}
EU MDR Quality Management System [Role of an eQMS]
The tough part for the medical device industry is that this landscape of regulations is constantly...