Medical device materials are an important determinant of the biological safety of a medical device.
Medical device materials are an important determinant of the “biocompatibility” (biological safety) of a medical device. However, the US FDA and EU Notified Bodies consider biocompatibility to involve more than just the device materials.
This presentation explains how US and EU regulators review biocompatibility and provides insight on how to meet their expectations.
What we will cover:
Rob Allen, Ph.D., Senior Associate, Regulatory Affairs, MCRA