MD&M East 2025
Regulatory Compliance Associates® will be at MD&M East in New York City May 20th- 22nd. Join us in the Sotera Health booth #838 with Nelson Labs and Sterigenics to get answers for any of your medical device quality, regulatory, compliance, lab testing, and sterilization needs.
To schedule a meeting with us, please fill out the contact us form at the bottom of the page email us at [email protected].
We will also be offering free a presentation in the Tech Theater.
Tech Theater Presentation:
Topic: ISO 10993-1: Key update on the new revision of this critical standard
Speaker: Thor Rollins, VP Global Segment Leader, Medical Device, Nelson Labs
Tech Theater, Booth 878
Tuesday, May 20, 2025
1:30 – 2:15p.m. PT
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.