Biocompatibility in 2026: How to Prepare for the New Regulatory Expectation

Join Paolo Pescio, MBA, ERT, Senior Scientific Director of Medical Devices at Eurofins and Geoff Moodie, Principal Biocompatibility Engineer at Zoll Medical, for an in-depth discussion on biocompatibility and what the latest regulatory changes mean for you.

Paolo is a current technical expert to the ISO committee that produced the new 2025 ISO 10993-1 standard, so you will have opportunity to hear the most current thinking. This Forum will be hosted by Geoff Moodie, who is also President of MDG Boston. They both have over 20 years of experience in medical device safety and efficacy testing.
Biological risk assessment is not just a checkbox—it’s a critical requirement for any medical device that comes into direct or indirect contact with human tissue, from implants to IV bags. With the new ISO 10993-1 standard released in November, regulatory agencies are already asking tough questions and expecting manufacturers to demonstrate compliance with this updated standard.
Are you ready to answer those questions confidently?
This session will explore the shift toward a risk-based approach, which now places greater emphasis on:

• Biological risk assessment through the full lifecycle of your product, including
• Shelf life
• In-service life
• Reprocessing
• Reasonably foreseeable misuse and how to address it
• Increasing alignment with ISO 14971 and a shift toward a risk-based approach

You’ll gain practical insights into what these changes mean for your product and how to implement strategies that satisfy regulators while ensuring patient safety. Whether you’re in R&D, regulatory affairs, or quality assurance, this discussion will help you stay ahead of evolving expectations and avoid costly delays or compliance issues.

Link to register: https://www.eventbrite.com/e/biocompatibility-in-2026-how-to-prepare-for-the-new-regulatory-expectation-tickets-1981619248516?aff=oddtdtcreator