Biocompatibility of medical devices – Common pitfalls and general strategies

ABOUT THE WEBINAR

The demonstration of biocompatibility plays an important role in proving that a medical device meets the essential safety and performance requirements set out in Annex I of the Medical Devices Regulation (MDR). The ISO 10993 series of standards consists of 20 parts and contains a large amount of information, but does not have a checklist character. Medical device manufacturers must therefore fundamentally understand what biocompatibility means and how they can ensure the required conformity with the MDR in this regard. In addition to general strategies in the field of biocompatibility, the seminar offers suggestions as to which tests are absolutely necessary and which can potentially be omitted. The conclusion is a presentation of common difficulties and mistakes.