AFDO RAPS Healthcare Products Collaborative
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Brian Edwards Headshot 1

Brian

Edwards

Fellow, Regulatory Affairs, Digital Health/Cybersecurity

Boston Scientific

Brian Edwards is a Regulatory Fellow specializing in Digital Health and Cybersecurity for Boston Scientific. He is focusing on internal and external global advocacy efforts related to Digital Health, Medical Device Software, AI/ML, Cybersecurity, and Quality Systems. He has over 30 years of experience in the medical device industry and over 25 years of experience as a Regulatory Affairs Professional. He holds a BS in Chemical Engineering and an MS in both Biomedical Engineering and Biostatistics. Brian has worked in R&D, Clinical Research, Quality Systems, and Regulatory Affairs. He has successfully led Regulatory Affairs Departments for medical device companies in the orthopedic, cardiovascular, audiology, electrotherapy, digital health, and neurosurgical product industries.

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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