Usage of Standardised Test Methods to Comply with the General Safety and Performance Requirements

You can register for this Pre-Conference workshop until Thursday 22 October via the RAPS Euro convergence website: https://www.raps.org/europe-2020/register. Once you have registered you will receive an email with the webcast link for the meeting.
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The Medical Device Regulation MDR 2017/745 was published on the 5th of May 2017 and entered into force twenty days later with its publication in the official European Journal. This regulation introduces up-to-date and state of the art expectations for the fulfilment of the essential principal of medical devices when declaring conformity to the European requirements. These requirements are listed in Annex I of the MDR and are named General Safety and Performance Requirements GSPR. During this workshop notified body, consultant and testing laboratory experts will exchange with you on the usage of standardized methodologies towards fulfilling these requirements.

Agenda:

9:00 Early Dial In All
9:30 Workshop Start – Welcome and Opening
Dr. Bassil Akra

9:40 GSPR of the Medical Device Regulation
Martin Witte

10:05 Risk Management Requirements ISO 14971
Peter Bowness

10:45 Q&A

11:00 Coffee Break

11:15 Comply with single fault safety and cybersecurity Requirements of the MDR - A practical approach
Prof. Dr. Christian Johner and Dr. Andreas Purde

12:45 Lunch Break

13:15 Biocompatibility Requirements ISO 10993 - View of a notified body and a test lab
Dr. Dominik Herzog and Dr. Christoph Lindner

14:45 Q&A and Conclusions
Dr. Bassil Akra