Twin Cities Chapter In Person Event: Regulatory 101: Medical Devices 2025

Whether you are new to Regulatory, support Regulatory (e.g., clinical, engineering, project management), or even a seasoned professional, join us for a day of learning the latest about medical device regulations impacting your daily work and opportunities for networking with seasoned industry professionals. Topics range from medical device regulations, Quality Management System Regulation, anticipated changes related to the new presidential administration, FDA Pre-submissions, FDA commercialization submissions (510(k), De Novo, PMA), advertising and promotional practices, clinical evaluations, changes to EU and international regulations, predetermined change control plans, post-market submission management, and working with FDA (Inspections, enforcement, and other topics). Speakers include medical device industry veterans, a Notified Body (TÜV SÜD) representative, and FDA (invited).

Registration Fees & Deadlines

Location

Medtronic Mahle Auditorium
8200 Coral Sea Street NE
Mounds View, MN 55112

Speakers

Event Sponsors 

Platinum Chapter Sponsors 

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.

Questions