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Medical devices are regulated by means of three EU-Directives (90/385/EWG, 93/42/EWG and 98/79/EG) as well as an additional directive in Europe. Harmonized standards are essential in the regulation of medical devices, as these standards represent the “state of the art” and therefore have a high relevance for medical device manufacturers (presumption of conformity).
One of the most important standards for medical device manufacturers is EN ISO 13485 “Medical Devices – Quality management systems – Requirements for regulatory purposes”. This standard describes the requirements for a management system and covers the design and manufacturing process of medical devices. The distribution of medical devices in Europe is based on a CE Certification, mostly in combination with a notified body who are primarily in charge of the supervision of medical devices. They audit the QM System of medical device manufacturers, hence the implementation of ISO 13485.
ISO 13485 has been revised recently. After a transition period, ISO 13485-2016 will come into force. Unfortunately, there are differences between ISO 13485-2016 and ISO 9001-2015 which has also been revised recently. Especially the topic risk management has a higher relevance in ISO 13485-2016 than in the old, but still current version. For example, risk management should now also be implemented in the management review. Furthermore, new requirements, coming from FDA´s 21 CFR 820 (Quality System Regulations, QSR), are also implemented. Examples are the introduction of a medical device file and the new subchapters regarding design transfer, design history file etc. Additionally, statistical methods become more important in designing a product and software validation is addressed more explicitly.
The following topics will be discussed regarding the revision of ISO 13485 in the view of an industry representative:
History of ISO 13485
What´s new in ISO 13485-2016?
Possible implementation strategies
regarding ISO 13485-2016
ISO 9001-2015 and ISO 13485-2016
How to close this gap?
ISO 13485-2016 and GMP for Medical
Devices (QSR, 21 CFR 820)
The target audience are people who are interested in the changes carried out during the revision of ISO 13485, mainly medical devices manufacturers. Companies which bring combination products to the market and therefore have to apply ISO 13485 are also addressed.
Ms Véronique Arnegger, Chemgineering Business Design GmbH, Stuttgart
Véronique Arnegger holds a diploma in business administration (Industry), International Regulatory Affairs Manager and Business Mediator. The last 15 years she worked within several leading positions within the medical device industry, especially within the quality management. In those functions, she was responsible for different Mock-, FDA and Notified Body Audits especially for the area of CAPA and CC. Since 2016 she is working with Chemgineering as Senior Consultant. In this function she is responsible for solving compliance problems and consulting medical device companies in preparation of FDA and Notified Body audits or technical documentation. She is also a lecturer.