Focus on Fudamentals: Big Changes in Medical Device Biocompatibility

This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates to ISO 10993-1, including a redefinition of device categorization and revised testing requirements. Day 2 covers updates to USP Class VI testing and how it will impact medical device materials. Day 3 offers guidance on adapting to these updates for existing products and in-process submissions, emphasizing proactive risk assessment, global regulatory nuances, and the importance of documentation and qualified personnel.