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

RECORDING WILL BE AVAILABLE TO MDG BOSTON MEMBERS AFTER THE EVENT

When & Where

Date: Wed Feb 11, 2026
Time: 12:00 – 1:30 PM
Location: Online

Abstract

A major update of the main biocompatibility standard, ISO 10993-1: 2025, is published.  The US voted against it.  Currently it is not recognized in the US and it is uncertain as to what is going to happen and when.  

How do you handle this if you are marketing both in the US and outside of the US?  What parts of the new standard did the FDA disagree with?  Perhaps as importantly when preparing a submission, what did they agree with?  

This is your chance to ask questions of someone who was in the room when these discussions were going on.

Come join us on Feb 11 to meet with ISO committee member 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.

Location: ONLINE

Time: 12:00 to 1:30 PM

Tickets

• MDG Boston Members: $25 
• Non-Members: $50 – Can be applied to a $95 Professional Membership: Click Here and use this 50Discount code at checkout. You will be sent the Zoom link before the event and also have access to the recording, an MDG Boston Members Only Benefit.
• Students: $20
• MDG Boston Staff & Sponsors – No Charge

(THE ZOOM LINK WILL BE PROVIDED BY EVENTBRITE 30 MINUTES BEFORE THE EVENT)

REGISTER HERE, UNLESS SELECTING THE $95 PROFESSIONAL MEMBERSHIP DISCOUNT OPTION

Panelists

Paolo Pescio, MBA, ERT
Business Unit Cluster Manager, Eurofins Medical Device Services Europe

Paolo Pescio is a strategic regulatory toxicologist with over 20 years of international experience in medical devices. He leads Eurofins Regulatory & Consultancy Services Italy and manages consultancy operations of Eurofins Medical Device Services Europe. Paolo is a European Registered Toxicologist, holds an MSc in Applied Toxicology and Biomedical Engineering, and is an active member of ISO/TC 194 and Convenor of CEN/TC 206/WG2. He is also an Adjunct Professor at the University of Bologna and a recognized expert in biocompatibility and risk management. Paolo has authored multiple articles and lectures widely on regulatory innovation and compliance strategies.