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.
Day 2:
Recent updates to USP Class VI testing and its role in medical device material qualification have reshaped how manufacturers evaluate and justify material biocompatibility. Traditionally used as a benchmark for material safety, USP Class VI is now recognized as a limited scope test that must be integrated into a broader, risk-based framework aligned with ISO 10993. This session will explore the key changes, clarify misconceptions, and provide practical guidance for incorporating USP Class VI testing into a modern biological evaluation strategy. Attendees will gain insights into how regulatory expectations have evolved, what the changes mean for materials testing and selection, and how to ensure compliance with both U.S. and global standards.
What you’ll learn by listening:
- The updated scope and limitations of USP Class VI testing
- How USP Class VI aligns (and differs) from ISO 10993 biocompatibility requirements
- When and how to appropriately use Class VI data in regulatory submissions
- The regulatory implications of relying solely on USP Class VI for material safety
- Practical tips for updating internal procedures and test strategies in response to the changes
