With changes to ISO 10993, chemical testing is more important than ever to support a medical device’s safety for market. Medical device manufacturers can no longer rely on biocompatibility testing alone to obtain regulatory approval.
Regulators will require detailed chemical information to support the direction of biocompatibility test plans. All chemicals should be identified. If unknown chemicals are listed in a chemistry report, your clients should be prepared to hear from regulators again – and with the shrinking number (and capacity) of notified bodies, this is an especially problematic scenario. Starting with complete chemical characterization can help you and your clients avoid unnecessary and costly regulatory delays.
Understand the ins and outs of ISO 10993 Part 1 and upcoming Part 17/Part 18 updates, as well as best practices and what to be aware of when analyzing a chemistry report by watching our latest webinar from WuXi AppTec’s regulatory experts Sandi Schaible, Senior Director of Analytical Chemistry, and Mark Cabonce, Director of Technical & Regulatory.
You will learn:
- How to interpret ISO 10993-1 and what changes are coming with the next release of Part 17 and Part 18
- Stages of complete biological evaluation
- Importance of complete chemical characterization and avoiding unknowns
- Best practices for developing test plans and analyzing chemistry reports