What does risk-based biocompatibility under the new ISO 10993-1 really look like?

Date:

June 16, 2026

Time:

4:00 pm ET

Presenter:

Taryn Meade Brow, Audrey P. Turley and Robert Dieker

The era of the “checklist” approach to biocompatibility is officially over. With the publication of ISO 10993-1:2018 and the recent 6th edition (ISO 10993-1:2025), regulatory bodies like the FDA and EU Notified Bodies have shifted their focus from animal testing to a sophisticated, data-driven Biological Evaluation Plan (BEP).

But what does this shift actually look like in practice? How do you move beyond Table A.1 to build a justification that satisfies regulators while potentially reducing unnecessary testing?

In this session of DeviceTalks Tuesday, we simplify performing risk estimation by breaking down the transition from an overall risk-based approach to identifying hazards and harms. We will explore how to integrate ISO 14971 risk management principles to assess not just intended use, but also reasonably foreseeable misuse and lifecycle evaluation.

Whether you are dealing with legacy devices or novel materials, this session provides a practical roadmap for leveraging chemical characterization, toxicological risk assessment (TRA), and bioequivalence to streamline your path to market.

In this webinar, you will learn about:

Decoding the New Standards: Identify the critical changes in the 2025 revision, including new definitions for Contact Days and the reorganization of biological effect tables.
Addressing Misuse and Lifecycle Evaluation: Discover how to evaluate biological risks beyond “time zero,” including the impact of reprocessing and off-label clinician use.
Regulatory Expectations: Gain insights into how the FDA and regulatory bodies around the globe evaluate a Biological Evaluation Report (BER) in 2026.

Presented by DeviceTalks

Audrey Turley

RM (NRCM), CBA (ASQ)
Biocompatibility Expert

Audrey Turley has over 25 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert, having performed all the in vitro tests offered at Nelson Labs, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods),...

Taryn Meade Brow

Senior Manager, EAS Technical Consulting

Taryn has over a decade of experience in medical device and pharmaceutical product development, biological safety evaluation, chemical characterization testing, and toxicology, along with a strong track record of collaboration with global regulatory agencies and involvement in the standards development process for the ISO 10993 series of standards. Taryn has degrees in Chemistry and Bioethics, and is an expert in design of testing and evaluation strategies for complex medical devices and combination products.

Robert Dieker

Expert Consultant

Robert Dieker has over a decade of experience in the medical device testing industry, with extensive expertise in supporting the biological safety evaluation of medical devices through technical consulting, laboratory coordination, and regulatory risk assessment activities. His expertise includes the development of Biological Evaluation Plans (BEPs) and Reports (BERs), material characterization evaluations, and interpretation of biocompatibility data in accordance with the ISO 10993 series and ISO 14971. Prior to his consulting work, Robert served as a Study Director, where he designed and executed studies related to sterilization validation, dose audits, and routine bioburden testing. His hands-on laboratory background strengthens his ability to provide practical testing strategies, develop clear technical documentation, and support regulatory submissions for global markets, including FDA and MDR. Robert also contributes to industry initiatives through standards working groups, cross-functional collaboration, and internal training and mentorship activities.

Tom Salemi

Editorial Director, DeviceTalks

DeviceTalks Editorial Director Tom Salemi has been writing and talking about the MedTech industry for over two decades. Prior to joining WTWH Media, Tom organized conferences, wrote feature articles and broke news for industry-leading business-to-business publications. Tom lives north of his native Boston with his wife, two sons, and Daisy the Dog.