Beyond Biocompatibility: Updated ISO 10993-1 and FDA Expectations for Particulate Evaluation in Vascular Devices

Recent updates to ISO 10993-1 and evolving FDA feedback are raising the bar for particulate evaluation in vascular medical devices. What was once a secondary consideration is now becoming a critical factor in regulatory submissions and device safety assessments.

This webinar will break down the regulatory drivers behind the shift, explain the practical implications for manufacturers, and outline best practices for designing and executing robust particulate testing strategies. Attendees will gain actionable insights into how to adapt their development and regulatory pathways to stay compliant and competitive in this changing landscape.