In this presentation, Thor will review the benefits of developing a Biological Risk Evaluation Plan to evaluate the Biocompatibility hazard of a device or combination product and how to address the danger to the patient. He will cover how to use extractable and leachable testing to evaluate risk and then how you can use the results to support the safety of the product.
Thor will discuss the recently released FDA guidance document regarding biocompatibility, which included:
How to add risk management into biocompatibility
How material/chemical characterization plays a role in biocompatibility

In addition we will cover what’s on the horizon for change in biocompatibility