Biocompatibility of medical devices – Common pitfalls and general strategies 

Proof of the biocompatibility of a medical device is one important aspect in demonstrating compliance with the General Safety and Performance Requirements, defined in Annex I of the MDR (Medical Device Regulation). The ISO 10993 series contains a large amount of information and has over 20 different parts, but does not include a checkbox approach. Therefore, manufacturers of medical devices need to have a broad understanding of biocompatibility and how to comply with it. This webinar highlights the general biocompatibility strategy and gives ideas about what to test and which tests can potentially be omitted. Finally, some common pitfalls and mistakes are presented. 


Date and time: Wednesday, 10 November 2021, 9.30 am (CET)

Your speaker: Dr Christoph D. Lindner | Team Lead Medical Device Testing                     

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