AFDO RAPS Healthcare Products Collaborative
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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.

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