Demystifying the FDA Regulatory Path and Profession for Medical Devices and Software

Wednesday, September 27, 11:30 a.m. – 1:00 p.m.

In-person, lunch provided, please register at the door, suggested arrival time 11:15 a.m.

Location: Discovery to Product (D2P), 1403 University Ave.

Presented by Discovery to Product (D2P) and co-sponsored by Forward BIOLABS and the Isthmus Project.

All commercial medical technologies are subject to federal regulations to ensure safety, efficacy, and performance. These processes and their impact on go-to-market timelines may be unfamiliar to academic researchers and start-up companies.

This panel will enhance your Food and Drug Administration (FDA) medical device regulatory knowledge, summarizing the path to market for medical device products including standard hardware/software devices, Software as a Medical Device (SaMD) and Artificial Intelligence (AI) applications.  A panel of regulatory affairs professionals will provide an overview of common medical device regulatory pathways as well as how and when to work with expert professionals.

This panel is intended for UW–Madison faculty, postdocs, graduate students and affiliates interested in translating research into commercial healthcare products and in exploring a career in regulatory affairs.

Pre-registration requested. If you need an accommodation to attend, please contact Jesse Lynch by September 13.

Suggested Parking:
University Avenue Ramp (Lot 20), 1390 University Avenue
Union South Garage (Lot 80), 1308 W. Dayton Street
Engineering Drive Ramp (Lot 17), 1525 Engineering Drive

Speakers:

Tracey Fox, Executive Director, Regulatory Affairs, Olympus Medical; Regulatory Affairs Professionals Society (RAPS) WI Chapter President

Carol Lindsay, Ph.D., RAC, Regulatory Affairs Program Manager, Promega, RAPS WI Chapter Vice President

Trishia Mercier, Head of Regulatory Affairs, Ambulatory Monitoring & Diagnostics, Philips; RAPS WI Chapter Secretary

Robin Martin, Co-founder and Chief Regulatory Strategist, Kinetic Compliance Solutions, LLC

Moderator: Aimee Arnoldussen, Innovation and Commercialization Mentor, Discovery to Product (D2P)

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