Mastering Biocompatibility Testing in a Shifting LandscapeEducation Sessions<img alt="" height="200" src="https://assets.swoogo.com/uploads/medium/3515146-65c25b6b62507.jpg" style="margin:10px;float:right;" width="300" /> Navigating the ever-evolving landscape of biocompatibility testing can feel like walking a tightrope. New manufacturing additives, process changes and FDA demands raise critical questions: When does a tweak trigger extra testing and when does it necessitate a full ISO 10993 deep dive? Attend this informative session to ensure your medical device is submission-ready. We’ll explore FDA’s hot-button biocompatibility concerns, current focus and anticipated future regulations. Learn which manufacturing changes and additives warrant additional testing, demystify the ISO 10993 framework and select the most efficient testing solutions. Gain practical insights from real-world case studies and industry experts who’ve tackled similar challenges. Don’t let biocompatibility testing become a roadblock to your success. Equip yourself with the knowledge and strategies to navigate the evolving landscape with confidence. This session is presented in collaboration with the Orthopaedic Surgical Manufacturers Association (OSMA), a device-company-led organization that works to enhance the implementation of global regulations and foster productive interactions between the orthopedic industry and regulators.

Description

Navigating the ever-evolving landscape of biocompatibility testing can feel like walking a tightrope. New manufacturing additives, process changes and FDA demands raise critical questions: When does a tweak trigger extra testing and when does it necessitate a full ISO 10993 deep dive? Attend this informative session to ensure your medical device is submission-ready.

We’ll explore FDA’s hot-button biocompatibility concerns, current focus and anticipated future regulations. Learn which manufacturing changes and additives warrant additional testing, demystify the ISO 10993 framework and select the most efficient testing solutions. Gain practical insights from real-world case studies and industry experts who’ve tackled similar challenges.

Don’t let biocompatibility testing become a roadblock to your success. Equip yourself with the knowledge and strategies to navigate the evolving landscape with confidence.

This session is presented in collaboration with the Orthopaedic Surgical Manufacturers Association (OSMA), a device-company-led organization that works to enhance the implementation of global regulations and foster productive interactions between the orthopedic industry and regulators.