Webinar

Part 2: Safety Assessment of Medical Devices

Learn about chemical characterization and recommended methods in ISO 10993-18 and ISO 10993-17

The importance of the physical and chemical properties of medical devices and device materials has led to updated requirements in the EU Medical Device Regulation (MDR) and the international ISO 10993 standards for biocompatibility. The requirements challenge industry to provide additional chemical analyses and toxicological data. In this webinar, you will learn about safety assessment by means of chemical characterization (~45 min). Please note that this webinar was recorded in late 2019. Since then the European Commission has postponed implementation of the MDR until 26 May 2021. This does not affect the guidance and relevance of the webinar.

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