Managing Biocompatibility Risk: Applying the New ISO 10993 Standards
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?