Managing Biocompatibility Risk: Applying the New ISO 10993 Standards

Thursday, October 24 11:00 AM - 11:45 AM

Location: 208AB


Event Information

Title: Managing Biocompatibility Risk: Applying the New ISO 10993 Standards

Description:

Documentation is playing a bigger role in submissions these days and are an important part of ISO 10993-1. Start with a biological evaluation plan (BEP) to identify device risk and identify appropriate mitigation steps (i.e. testing). The BEP and testing culminate information that feeds into a Biological Evaluation Report (BER). To be effective, you must be able to communicate device specific information and the factors influencing your approach to biocompatibility.

Topics covered include:
  • An overview of the new ISO 10993-1
  • Performing a Biological Evaluation Plan
  • Overview of the "Big Three" including new in vitro alternatives
  • What is needed in a Biological Evaluation Report for the FDA?

Type: Session

Badge Type: Paid


Speakers


Tracks