Twin Cities Chapter In Person Event- Biocompatibility Essentials for Medical Devices: From ISO 10993 to US and EU Regulatory Expectations

A practical session on biological evaluation of medical devices: ISO 10993, US FDA & EU MDR expectations, and chemical characterization. Hosted by TUV SUD with Medtronic.

1pm – 5pm CDT 27 August 2026 + Add to calendar New Brighton, MN TÜV SÜD New Brighton Laboratory

Join the RAPS Twin Cities Chapter for a practical, collaborative session on the biological evaluation of medical devices hosted by TÜV SÜD in partnership with Medtronic. Bringing together regulatory, toxicology, and testing-lab perspectives, this event is designed to help regulatory professionals confidently plan, interpret, and defend the biocompatibility evidence used to support device safety across global markets.

Through real-world examples and expert dialogue, attendees will explore how the ISO 10993 framework is applied in practice, how US (FDA) and EU (MDR) expectations differ, and how chemical characterization and toxicological risk assessment are reshaping biological evaluation. The session emphasizes clarity, regulatory relevance, and effective cross-functional communication between regulatory, R&D, and testing partners.

Learning Objectives

By the end of this session, participants will be able to:

Apply a risk-based approach to biological evaluation using the ISO 10993-1 framework and biological evaluation plan (BEP)
Compare key U.S. and EU regulatory expectations for biocompatibility, including FDA guidance and EU MDR considerations
Describe how chemical characterization and toxicological risk assessment (ISO 10993-18 / -17) support or reduce animal testing
Understand key concepts and common areas of regulatory concern in biological evaluation, such as:
- Selection of biological endpoints and test article preparation
- Use of chemical characterization data in lieu of biological testing
- Justifying gaps, equivalence, and use of existing data

Why Should You Attend?

Understand how the ISO 10993 family of standards structures a risk-based biological evaluation
Gain insight into current U.S. and EU approaches to biocompatibility evaluations
Learn how US (FDA) and EU (MDR) expectations for biocompatibility differ — and where they align
See how chemical characterization (extractables & leachables) and toxicological risk assessment fit into a modern evaluation strategy
Recognize common gaps that lead to regulatory questions or deficiencies
Gain insight into the role and capabilities of an accredited biocompatibility testing laboratory
Improve confidence when discussing biological safety with toxicology, testing, and regulatory stakeholders

Who Should Attend?

This session is designed for:

Regulatory affairs professionals (all levels)
Quality, R&D, and design assurance partners
Toxicologists and biocompatibility / biological evaluation specialists
Testing, chemistry, and materials engineering partners
Anyone involved in generating, interpreting, or defending biocompatibility evidence for medical devices

Agenda

1:00 – 1:30 PM	Welcome, Check-in & Introductions Registration and networking
1:30 – 1:35 PM	Welcome & Opening Remarks Introduction by Tom Brumbaugh (TÜV SÜD) RAPS Twin Cities Chapter welcome to members
1:35 – 2:20 PM	Session 1 — ISO 10993-1 Updates Risk-based approach to biological evaluation Panel contribution: industry perspective
2:20 – 3:05 PM	Session 2 — US and EU Expectations on Biocompatibility Regulatory expectations in the U.S. and Europe Considerations for supporting global market access
3:05 – 3:20 PM	Break
3:20 – 4:05 PM	Session 3 — Best Practices for E&L / Chemical Characterization Extractables & leachables considerations (ISO 10993-18) Reducing animal testing through chemistry-based approaches
4:05 – 5:00 PM	Panel Discussion, Q&A and Closing Remarks Cross-functional dialogue with speakers and attendees
5:00 PM onward	Optional Lab Tour Guided tour of the TÜV SÜD biocompatibility, chemistry, and microbiology laboratories

Location

TÜV SÜD New Brighton Laboratory
141 14th St NW
New Brighton, MN 55112

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.