Medical device chemical characterization testing per ISO 10993-18 is often the leading source of delay, cost overrun, and regulatory questions in a manufacturer’s biocompatibility program. Problematic study outcomes tend to be associated with a few recurring issues, with most difficulties arising not from the analytical chemistry itself, but rather from key decisions made throughout the process.
This 60-minute webinar will discuss real-world case studies that encountered testing challenges. The program will present solutions that highlight the importance of extractable study design, cross-functional integration with toxicologists, clinical use considerations, and regulatory alignment to optimize testing outcomes and reduce the potential need for retesting.
Case study topics include:
- Overly aggressive extractable studies: problematic outcomes from strictly following the ISO standard as well as reasonable alternatives
- Simulated use study considerations: what constitutes a clinically relevant worst case, and how to refine the testing and assessment approach
- Challenges with testing of degradable/resorbable devices and alternative strategies to consider
- Cross functional evaluation planning for an integrated risk narrative
An audience Q&A session will follow the technical presentation.
