AFDO RAPS Healthcare Products Collaborative
Mac Mckeen 2022




Boston Scientific Corporation

Mac McKeen has 30 years of experience in the medical device industry in regulatory and quality roles focused on the development, clinical study, and regulatory approval of cardiovascular devices and is currently a fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize. He also serves as an adjunct professor at the University of Minnesota instructing a 4000 level course and graduate level course on medical device development and is also a faculty director within the College of Continuing and Professional Studies. He is actively involved in advocacy and collaboration with the FDA through industry associations including AdvaMed, MDIC, RAPS and Medical Alley. He holds a B.S. in Industrial Technology from Iowa State University and an M.B.A. from the University of Dallas and is RAC certified.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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