ISO 10993-1 Webinar: What You Need to Know in 2026
Join us for an in-depth webinar exploring the latest updates to ISO 10993-1 and the way forward for biocompatibility assessments. Our experts will break down what has changed, why it matters, and how manufacturers should respond, with a clear focus on practical application for both new and legacy medical devices.
With extensive experience supporting biological evaluations across a wide range of medical devices and combination products, our specialists will guide you through the evolving expectations around contact duration, foreseeable misuse, cumulative exposure, and risk-based justification. The session will bring the standard to life through case studies, highlighting where assessments are most likely to be impacted and how to avoid unnecessary testing, delays, or regulatory challenge.
Whether you are developing a next-generation device or managing products already on the market, this webinar will provide clarity on what needs to be reviewed, what can be justified, and the most effective way forward under ISO 10993-1. The session will conclude with a live Q&A, giving you the opportunity to put your questions directly to our experts and discuss how the changes apply to your specific products and scenarios.
Don’t miss this opportunity to strengthen your biocompatibility strategy and approach regulatory expectations with confidence.
Authors:
Elena Henderson
Elena is a consultant on Biological evaluations for Medical devices within ISO 18562 and ISO 10993 series. Elena has extensive experience with effective submissions to UK, EU and US authorities.
Caroline Aiken
Caroline leads the Physical Characterisation team at Cormica Bradford. She has over 15 years experience supporting the complex generics industry including combination medical devices and wider pharmaceutical market in a CRO setting.
Luminita Moraru
Lumi is Analytical Chemistry Manager at Cormica MET, with expertise in designing studies to comply with ISO10993 standards for contact medical devices, and ISO18562 on gas pathway medical devices as part of the Biocompatibility process.
James Booker
James Booker is a Biocompatibility Moderator at Cormica’s UK Wickham Micro site. He’s responsible for the proper conduct and GLP compliance of biocompatibility studies for medical devices.
Why Watch?
- Understand the key changes in ISO 10993-1:2025 and how they differ from the 2018 edition
- Learn how contact duration and foreseeable misuse can trigger reclassification and new testing expectations
- See how updated requirements affect legacy devices already on the market
- Explore how chemical characterisation, toxicological risk assessment, and biocompatibility work together in case studies
Gain clarity on what action is truly required, and what can be scientifically justified without unnecessary testing
This webinar will be especially useful for professionals involved in the design, evaluation, testing, and regulatory approval of medical devices and combination products, including:
- Regulatory Affairs Managers and Specialists
- Quality and Compliance Professionals
- R&D and Product Development Engineers
- Biocompatibility and Toxicology Specialists
- Clinical and Medical Affairs Professionals
Cormica’s mission is to improve patients’ lives by providing comprehensive testing services, enabling clients to launch and release their products safely and rapidly across the world.
With Cormica as your testing partner, you gain access to comprehensive physical and functional testing solutions that support safer medical device design and successful global submissions. From connector compatibility and leakage assessment to verification of delivery performance, packaging integrity, and durability under real-world conditions, our teams ensure every component performs as intended throughout its lifecycle. Whether you are implementing the latest ISO 80369 revisions or strengthening the overall safety profile of your device, we are here to guide you with accredited capabilities and regulatory expertise. To discuss how we can support your development and compliance needs, contact us at sales@cormica.com