This webinar delves 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
Viewers 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.