Twin Cities Chapter In Person Event: The EU AI Act: What Medical Device Manufacturers Need to Know

The European Union’s Artificial Intelligence Act (EU AI Act) introduces a risk-based framework that will significantly impact medical device manufacturers using AI and machine learning in their products. Join the Twin Cities RAPS Chapter for an interactive in-person session, hosted at TÜV SÜD’s facility, to gain insights from regulatory experts on the scope of the Act, its alignment with the Medical Device Regulation and In Vitro Diagnostic Device Regulation (MDR/IVDR), and what companies can do now to prepare. The session will include expert presentations and time for Q&A with the audience.

Before the educational session begins, attendees are invited to network and participate in an optional guided tour of TÜV SÜD’s Medical Device Testing Center of Excellence in New Brighton, Minnesota — one of North America's most comprehensive medical device testing facilities.

This event is generously sponsored by TÜV SÜD, providing the event facility, refreshments, lab tours and event speaker!!

Agenda

5:00 PM – 6:00 PM | Registration, Networking, Light Refreshments, and Optional Lab Tours

• Check-in opens for all attendees
• Optional guided tours of TÜV SÜD’s Medical Device Testing Center of Excellence

6:00 PM – 6:45 PM | Educational Panel Session

• The EU AI Act: What Medical Device Manufacturers Need to Know
  Speaker: Kenneth Fuh, IVD & MDSW Product Assessment Expert, TÜV SÜD

6:45 PM – 7:15 PM | Audience Q&A

• Live Q&A session with Marco Caproni

7:15 PM – 7:30 PM | Closing Remarks

• Comments from TÜV SÜD and RAPS representatives

Speakers

JP Hong
Lead Auditor, TÜV SÜD

JP Hong is a Lead Auditor at notified body TÜV SÜD, specializing in medical devices with a focus on active devices, including AI software. He has extensive experience in regulatory and quality matters for devices such as computer-aided diagnostics, digital radiography, endoscopic equipment, and clinical chemistry systems. JP holds a Bachelor’s degree in Biomedical Engineering from Yonsei University, a Master of Science in Regulatory Science from Johns Hopkins University, and a Master of Public Health in Health Policy from Harvard University.

Location

TÜV SÜD America Inc.

141 14th St NW
Saint Paul, MN US 5112

Sponsor

TÜV SÜD
Providing the event facility, refreshments, lab tours and event speaker.

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 support@raps.org. 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 support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.