Biocompatibility Testing: In-vitro vs. In-vivo – Recent Developments and Acceptance throughout different regulatory authorities

Biocompatibility Testing: In-vitro vs. In-vivo – Recent Developments and Acceptance throughout different regulatory authorities.

Biocompatibility Testing: In-vitro vs. In-vivo – Recent Developments and Acceptance throughout different regulatory authorities.

There is a strongly increasing demand to replace in-vivo methods with in vitro approaches for medical device biocompatibility testing not only driven by public interest but as well from regulatory agencies with the UK as latest example planning to phase out in vivo studies in the coming years.

In this webinar, we will cover the latest regulatory updates in the context of the updated ISO 10993 standards, explore in vitro test methods and strategies, and compare acceptance by different global authorities including FDA and Notified Bodies. The theoretical background will be complemented by real case studies, challenges, and pitfalls to give practical insights who to navigate in this evolving landscape.

Why Attend?

• Stay Ahead of Regulatory Changes: Learn about the latest updates in ISO 10993 and global trends toward in vitro testing.
• Understand Global Acceptance: Compare how FDA, EU Notified Bodies, and other authorities view in vitro vs. in vivo approaches.
• Gain Practical Insights: Explore real case studies, common challenges, and strategies to avoid pitfalls.
• Shape Future Testing Strategies: Discover how to align your biocompatibility plans with evolving expectations and reduce reliance on animal studies.

Who Should Join?

• Regulatory Affairs Professionals: Ensure compliance with changing biocompatibility requirements.
• Medical Device Manufacturers: Optimize testing strategies for faster approvals and cost efficiency.
• Quality & Risk Management Teams: Understand implications for product safety and risk assessments.
• R&D and Laboratory Specialists: Learn about innovative in vitro methods and their practical application.