Medical device testing for biocompatibility – MDD and MDR requirements  

The transitional period of the Medical Device Regulation (MDR) has been extended by one year. Nevertheless, manufacturers have to work on the General Safety & Performance Requirements (GSPR) of the MDR which differ from the previous Essential Requirements (ER) of the MDD. One important part of the GSPR is biocompatibility. The main questions addressed by this webinar are how to address this topic, which standards to use and which changes apply. It provides a detailed explanation of the risk-based approach, following the ISO 10993-1 and the ISO 10993 series which is key for verification of biocompatibility. The webinar rounds off the topic by explaining some aspects of how packaging influences biocompatibility.

Date and time: Tuesday, 3 November 2020, 5:30 pm (CET)

Your speaker: Dr. Christoph D. Lindner, Team Leader Medical Device Testing


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