Carole C. Carey is the Founder of C3-Carey Consultants LLC, a regulatory consulting firm providing advice, solutions and strategic approaches to the medical device industry. Prior to this, she was with the Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA). She has over 23 years of experience as a Scientific Reviewer (peer-reviewed expert), Liaison to several Standards Development Organizations, International Affairs Advisor/Director of International Staff, and a recipient of the FDA Commissioner’s Special Citation. Carole participated in the Mike Mansfield Fellowship Program as an Expert Regulatory Review Scientist and representative of the U.S. FDA, Health and Human Services and served a year full-time placement in Japan’s Ministry of Health, Labour and Welfare and Japan’s Pharmaceutical and Medical Devices Agency.

She is a chapter author of several books: Medical Device Regulatory Affairs in Asia (2013), The Handbook of Cuffless Blood Pressure Monitoring (2019), and Clinical Engineering Handbook (2020). Carole holds a Bachelor of Electrical Engineering degree from The Johns Hopkins University and Master of Engineering Science degree with a concentration in Computer Engineering from Loyola University, Maryland, USA.

Currently serving as Chair of the IEEE Engineering in Medicine and Biology Society (EMBS) Technical Committee on Standards, Carole’s Committee provides technical oversight to over 20 Standards Development Working Groups and Industry Connections Teams. She is a member of the IEEE Translational Engineering and Healthcare Innovation, IEEE Future Directions Initiatives (Brain, Blockchain), and an Associate Editor of the IEEE Open Journal of EMB. Carole is a Senior Member of the IEEE and IEEE-Eta Kappa Nu Society. She was a recipient of an IEEE Standards Association (IEEE SA) Standards Medallion Award and an IEEE MGA Innovation Award.