March 2020

White Paper: Biological Evaluation of Medical Devices – Assessment of Biocompatibility

As a result of the MDR in combination with the 2018 modification of ISO 10993-1, evaluation of the biological safety of medical devices has become more of a focus for notified bodies. Find out how ISO 10993-1:2018 can be used as a tool to evaluate the biological safety of a medical device and how to structure the biological evaluation as a three-tiered approach.