The Biological Evaluation Puzzle: Building a Complete ISO 10993 Strategy
This eight-part webinar series explores the evolving landscape of ISO 10993 biological evaluation and the increasing need for manufacturers to build scientifically rigorous, risk-based justifications rather than relying on traditional testing frameworks alone.
This webinar series connects materials, chemistry, toxicology, exposure assessment, lifecycle considerations, supplier information, and implantation evaluation. Participants will gain a deeper understanding of how modern biological evaluation integrates multiple disciplines into a single defensible strategy.
Each session examines critical decision points that influence regulatory expectations, helping manufacturers strengthen endpoint rationales, anticipate emerging evidence requirements, and develop biological evaluations that are both scientifically credible and review ready.
As the series progresses, attendees will explore complex topics shaping the future of medical device safety assessment, including analytical chemistry advances, Threshold of Toxicological Concern (TTC) and Analytical Evaluation Threshold (AET) considerations, ethylene oxide residual risk, device reprocessing, end-of-life impacts, and long-term implant evaluation. The series concludes with a forward-looking discussion on New Approach Methodologies (NAMs) and their growing role in biological evaluation programs. Together, these sessions provide regulatory, quality, toxicology, and R&D professionals with a comprehensive framework for understanding current expectations, addressing emerging challenges, and preparing for the next generation of biological evaluation strategies.
On-Demand Webinars Now Available
Complete the form at the bottom of this page to access the available webinars on demand from this series.
Part 1 – The Corner Piece: The New Logic of ISO 10993 Biological Evaluation
Speaker: Thor Rollins
This opening webinar introduces the evolving logic behind ISO 10993 biological evaluation. Attendees will learn how to move beyond a checklist-based testing approach and build a risk-based strategy that connects materials, chemistry, toxicology, exposure, clinical context, and risk management into a clear, scientifically credible, and defensible biological evaluation.
Part 2 – Building Reliable Edges: Four Critical Areas for Manufacturers in ISO 10993-1
Speaker: Audrey Turley
This webinar examines four areas that can significantly influence biological evaluation planning: risk estimation, bioaccumulation, lifecycle evaluation, and foreseeable misuse. Attendees will gain a clearer understanding of how these considerations can affect testing decisions, increase evidence requirements, and create regulatory review challenges if they are not addressed with a strong scientific rationale.
Part 3 – The Picture Emerges: Understanding TTC, AET, and the New Chemistry Reality
Speaker: Taryn Meade Brow
This webinar explores how evolving Threshold of Toxicological Concern and Analytical Evaluation Threshold expectations are changing chemical characterization programs. Attendees will learn why lower thresholds can identify more compounds, increase toxicological assessment demands, and require more thoughtful decisions about analytical depth, patient exposure, cost, and overall biological risk.
The following are the upcoming live webinars you are welcome to register for here and one registration provides access to the full 8-part webinar series: Live Webinar Registration
Part 3 – The Picture Emerges: Understanding TTC, AET, and the New Chemistry Reality
Part 4 – Connecting the Pieces: Exposure, EO risk, and the Reality of 10993-7
Part 5 – Seeing the Big Picture: End-of-Life for Single Use Devices
Part 6 – Seeing the Big Picture: End-of-Life for Reprocessed Devices
Part 7 – The 3D Piece: Implantation Testing and Long-Term Thinking in Modern Biological Evaluation
Part 8 – The Missing Pieces: NAMs and the Future of Biological Evaluation
Learn more about the presenters below
