We are happy to announce that Nelson Labs along with our colleagues from Regulatory Compliance Associates will be exhibiting at this year’s MEDevice Silicon Valley expo in Santa Clara, California, November 19-20, 2025. Visit us in booth # 1042. We will have consultants available to answer any of your testing, compliance, and sterilization questions.
Join our Tech Theatre presentation:
Location: Innovation Spotlight Theater (757)
Day/Time: November 19, 1:30-2:15pm
Title: Life Cycle Evaluations in Biocompatibility
Abstract:
As medical devices evolve in complexity and cost making reuse a more prevalent necessity, the need for robust life cycle evaluations in biocompatibility has never been more critical. This presentation explores the expanding scope of biocompatibility assessments under the newly revised FDIS ISO 10993-1 standard, with a particular focus on the implications for shelf-life and reprocessing cycles. Attendees will gain insight into how material degradation, cumulative exposure, and repeated sterilization impact biological safety over time. We will examine strategies for integrating life cycle considerations into risk assessments, including the evaluation of chemical and physical changes that may occur during storage and reuse. By aligning testing strategies with these new requirements, manufacturers and regulators can better ensure the long-term safety and performance of medical devices throughout their intended lifespan. The main take-aways for this presentation are:
- How to incorporate shelf-life and reprocessing cycles into biocompatibility assessments
- Key updates in the FDIS ISO 10993-1 Standard impacting life cycle evaluations
- Practical strategies for aligning testing protocols with life cycle based risk assessments
Presenter: Audrey Turley, B.S., RM (NRCM), CBA (ASQ), Director Lab Operations, Biosafety Biocompatibility Expert
To learn more about the conference, please visit here.
