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 1:
Significant updates are coming to ISO 10993-1, the cornerstone standard for the biological evaluation of medical devices. This webinar will provide an in-depth look at the anticipated revisions and their significance for manufacturing and regulatory teams. Key changes include a reimagining of how device categorization is approached, rendering the familiar Table A.1 obsolete. The updated standard introduces revised testing requirements — some tests will be newly required, others removed — altering how biocompatibility is assessed.
In this presentation you will:
- Understand the major revisions coming to ISO 10993-1
- Learn to navigate device categorization
- Discern how testing changes will impact your current biocompatibility strategy
