Carole C. Carey, IEEE Senior Member and Eta Kappa Nu Honor Society.

Carole chairs the IEEE Engineering in Medicine and Biology Society (EMBS) Technical Committee on Standards, an Associate Editor of the Open Journal EMBS, IEEE EMB Translational Engineering and Healthcare Innovation Steering committee, IEEE SA Industry Connections Program Committee member, and currently IEEE Region 2 WIE Coordinator/Chair.

Carole is Founder and CEO of C3-Carey Consultants, LLC, consulting in medical device technologies, clinical trial protocol development, and regulatory intelligence to bring innovative and safe medical products to commercialization. Prior to this, she was a Peer-reviewed Expert Regulatory Review Scientist at the US Food and Drug Administration (FDA) Medical Device Program, Center for Devices and Radiological Health (CDRH). Carole was active in the CDRH AED (automated external defibrillator) Task Force and made significant contributions to the AED Early Defibrillation and Public Access Program, a critical link in the Chain of Survival. Additionally, she was a Mansfield Fellow and a visiting regulatory scientist in the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical and Medical Devices Agency (PMDA). Post fellowship, Carole served as International Advisor and Director of International Staff.

She has a BS in Electrical Engineering from Johns Hopkins University and Masters of Engineering Science (Computer Engineering) from Loyola University, Maryland.