Michael McSweeney

Strategic MedTech & Digital Health Leader
Biography

Michael has over 20 years of Healthcare and MedTech experience in Regulatory, Clinical, and Quality via both-in-house and consulting roles in venture-backed startups and Fortune 500 device companies. With a Biomedical Engineering background, he enjoys working closely with cross-functional teams and providing strategies for achieving regulatory approvals for Class I/II/Ill investigational and commercial devices, including AI/ML software. Michael received Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS), Clinical Trials Design and Management Certification from the University of California, and is a member of the Heart Rhythm Society (HRS). Passions include helping deliver innovative therapies to patients to improve lives, enjoying aviation, sports, and spending time with his family.

Michael McSweeney Headshot