We are happy to announce that Nelson Labs and Regulatory Compliance Associates will be exhibiting at this year’s MD&M Minneapolis trade show on October 21 – 22, 2025. Visit us in booth # 3026.
We will have consultants available to answer any of your lab testing and compliance questions. We hope to see you there!
Tech Theater Presentations
Addressing Updates to ISO 10993-1 and the FDA’s New Emphasis on Particulate Matter in Cardio/Vascular Devices
Date & Time: Tuesday, October 21, 2025, from 1 – 1:45 pm
Location: MedTech Theater, Expo Education, MD&M West
Abstract: ISO 10993-1 will be revising by the end of 2025 and many questions exist from industry about what the changes mean for currently marketed devices as well as those which are being prepared for submission. At the same time, increased scrutiny from FDA on particulates (processing residuals, mechanical wear etc.) from vascular devices has led to increased scrutiny which will be reviewed. We will discuss the updates including when re-evaluation is (or isn’t) needed, strategies for gap analysis, documentation and personnel qualifications, anticipated regional adoption of the standard with associated regulatory pathways, transitional complexities of in-process submissions and keys to continued regulatory success.
Speaker: Christopher Parker, Principal Biocompatibility Expert, Nelson Labs
