Drop by our booth #1042 at MEDevice Silicon Valley Conference which will be held at Santa Clara Convention Center, Santa Clara, CA on November 20-21, 2024.
This conference focuses on-
- New product innovations
- Sourcing Medical Device components
- Expert education on topics such as AI/ML, accelerating product design and development, navigating the changing regulatory landscape etc.
- and many more…
To learn more about the conference, please visit here.
Presentation: ISO 10993-1: Key meeting Updates and Future Directions – Navigating the Latest Changes and Next Steps in Biological Evaluation of Medical Devices
Tech Theater Presentation
Presenter: Thor Rollins, VP Global Segment Leader, Medical Device
Date: Nov 20, 2024
Time: 12:30- 1:15 pm
Abstract: This presentation will delve into the latest updates to ISO 10993-1, the cornerstone standard guiding biocompatibility assessment for medical devices. The most current updates out of the ISO meetings in October, introduces a more dynamic, risk-based framework. These changes carry implications for device manufacturers and regulatory professionals running biocompatibility studies. In the presentation you will learn:
- Key updates include a stronger emphasis on a risk-based approach, moving away from prescriptive testing protocols.
- New emphasis on chemical characterization, where the new ISO 10993-1 improves the ability to predict device safety and mitigate potential toxicological risks.
- The incorporation of endpoint-specific risk assessment such as changes on devices requiring genotoxicity evaluations.
- End of life evaluations
Attendees will gain insights into the practical implications of these changes, including how to adapt biocompatibility testing strategies, documentation practices, and regulatory submissions. This presentation will also discuss the broader impact of these updates on global harmonization of biocompatibility standards and their alignment with other regulatory frameworks, helping professionals ensure compliance while enhancing product safety and innovation.
