Qualitätsmanagement für Hersteller von Medizinprodukten

Please note: This publication is only available in German.

The regulatory requirements for the quality management systems of medical device manufacturers are stringent and varied. It is essential to act in line with national, European and international standards and regulations.

Which standards and regulatory requirements are relevant here?

“Qualitätsmanagementsysteme für Hersteller von Medizinprodukten” is a practical guide to DIN EN ISO 13485:2021-12, taking into account

• MDR (EU) 2017/745
• IVDR (EU) 2017/746
• FDA-QMSR (US)

How does the book aid the implementation of DIN EN ISO 13485, the MDR, the IVDR and the QMSR?

It provides a structured, comparative overview of the regulatory requirements for quality management systems (QMS) used by medical device manufacturers. The current regulatory and legal requirements for medical devices and their quality management systems are summarized in a clear and accessible manner. In addition, the relevant bodies – such as institutes and public authorities – are listed, along with references to further sources of information.

This guide translates normative and regulatory requirements into actionable steps for the quality management system. Topics covered include:

• Establishment and further development of a QMS in accordance with DIN EN ISO 13485
• Responsibility of top management and leadership responsibility
• Management of resources and infrastructure
• Product realization and manufacturing process planning 
• Measurement, analysis and improvement, including continuous optimization 

A comprehensive glossary explains key terms from DIN EN ISO 13485, the MDR and the IVDR, making it easier to interpret requirements and helping to ensure consistent documentation.

What else does this publication offer?

• A systematic overview of current legal and regulatory requirements for medical devices.
• An overview of the roles of institutions, public authorities and other bodies, with references to where you can find out more.
• Support in shaping a compliant, auditable quality management system that is logically and transparently designed.
• Help to ensure demonstrably thorough and safe operations in development, production and quality assurance.

Included in this book:

• Legal requirements for medical devices
• Fundamentals of Quality Management
• Introduction to DIN EN ISO 13485:2021-12
• Quality Management System
• Responsibility of top management
• Resource management
• Product realization
• Measurement, analysis and improvement
• Terms and their definitions from DIN EN ISO 13485:2021-12
• Terms and their definitions from EU Regulation 2017/745
• Terms and their definitions from EU Regulation 2017/746
• List of figures

This book is for:

Medical device manufacturers, managing directors, quality management representatives, quality assurance staff, risk managers.

Summary 

This practical guide provides structured support for the implementation and further development of quality management systems for medical devices. It combines the requirements of DIN EN ISO 13485 with the MDR, IVDR and QMSR, and facilitates their consistent implementation in day-to-day business operations.