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.
For existing, marketed products, the revised standard generally will not necessitate immediate re-evaluation unless significant device changes are implemented. However, manufacturers must proactively review current biocompatibility evaluations, conduct thorough data gap analyses, and assess whether historical information sufficiently addresses new requirements. Critically, the standard introduces more stringent requirements for documentation and for the qualifications of personnel conducting biological evaluations, demanding a higher level of expertise and verifiable records.
Furthermore, we address the complexities surrounding in-process regulatory submissions and global interpretations. Regulatory agencies and reviewers worldwide will interpret the updated document with subtle variations, and thus, knowing each country’s stance may be crucial to the success of a submission. This presentation provides strategic considerations for navigating these transitional challenges, aiming to ensure continuous compliance and streamline regulatory pathways.
In this webinar, you will learn:
- Existing products: When re-evaluation is (or isn’t) needed.
- Proactive review: Strategies for data gap analysis.
- Stricter requirements: Documentation and personnel qualifications.
- Global interpretations: Understanding regional differences.
- Targeted submissions: Crafting region-specific strategies.
- In-process submissions: Navigating transitional complexities.
- Compliance & Streamlining: Keys to continuous regulatory success.