Mon Bien 2nd Annual Medical Device Biocompatibility & Risk-Safety Summit

This session will cover:

• Key considerations for reusable medical devices

• How to approach their End-of-Life cycle evaluations?

• General testing and assessment strategies

• Regulatory perspectives: EU MDR vs. FDA

Biography

Elisabet Jamez holds a master’s degree in industrial engineering in Chemistry and joined Nelson Labs in 2019. Elisabet is subject matter expert (SME) in extractables and leachables testing for medical devices. She has years of experience in developing extractables and leachables study set-ups and writing the subsequent reports. In 2023, she evolved in her role to become part of the Nelson Labs Expert Advisory Services team as Biocompatibility Expert. Elisabet uses her extensive knowledge in extractables and leachables to write biocompatibility assessments that are targeted for regulatory submissions all over the world and is also an active member of several International Organization for Standardization (ISO) committees related to the biological evaluation of medical devices.

This session will cover:

• Major changes in ISO 10993-1:2025—updated concepts of biological risk, expanded guidance on chemical characterization, revised material/clinical considerations, and clearer expectations for justification over testing.
• Impact to industry workflows—how the new edition affects testing strategies, documentation, and decision-making, including shifts toward evidence-based, chemistry-first approaches.
• Regulatory adoption and global alignment—anticipated timelines and impact on FDA, EU MDR, and other regulatory bodies as they integrate the updated framework into submission expectations.
• What’s next for ISO 10993—a forward look at the standards still under revision (e.g., Parts 17, 18, 33), emerging topics such as nanomaterials and endpoints consolidation, and how the committee is shaping the next evolution of the biocompatibility paradigm.

Presenter: Thor Rollins, Vice President, Global Market, Segment Leader—Medical Device, Nelson Labs

Biography

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles on biocompatibility topics. He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI) TC 194 and 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, discussing biocompatibility methods, and voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare clients for changes in testing.