The Chemical Characterization Puzzle: Is There a Solution?
In today’s ever-changing regulatory environment for the biological safety of medical devices, manufacturers are often faced with the challenge of material or chemical characterization. Although ISO 10993–18 provides a good guide for this evaluation, regulatory expectations and evolving science continue to provide challenges in these ever-important screening studies. Regulatory focus remains diligent on the screen for confirmed and confident chemical entities that may leach from medical devices and their toxicity levels. In this webinar, NAMSA experts discuss the top challenges for today and how to address them. We highlight many of the items that are seen in regulatory responses, both in the US and also from global agencies around the world.
Attendees can expect to walk away with a better understanding of:
- Designing material or chemical characterization studies with the best approach to generating data for global agencies
- How device manufacturers can work with a laboratory to provide information, ensuring the best results for a study
- Identifying unknowns
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