MDR: Biological Evaluation of Medical Devices (10779)

The evaluation of the biocompatibility of medical devices is a requirement of the current Medical Device Regulation (MDR 2017/745). The way in which patient risk is assessed has evolved considerably in recent years, and as described in the ISO 10993-1 guideline, the evaluation must be performed within the scope of a risk management process. The old days of systematic testing are over, and new regulations require manufacturers to have greater control over all the processes involved in manufacturing a medical device. 

This webinar will briefly explain the regulation in place and introduce the concept for the biological evaluation of medical devices, from the Biological Evaluation Plan (BEP) to the Biological Evaluation Report (BER). The following topics will be covered:

• Brief overview of current regulations for the biological evaluation of medical devices
• What does biocompatibility mean? 
• Global process of the biological evaluation: the main steps 
• The role of chemical characterization in risk evaluation 
• Toxicological Risk Assessment (TRA)

Duration: approx. 90 minutes
Language: English | Handout: English

...more from your speaker Dr. Severine Colas...

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Note on contingent call-off: When booking this webinar described here, one unit will be deducted per participant.

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