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Caroline Rhim, PhD

Founder and Principal Consultant
Evera Regulatory Advisors

Caroline Rhim, PhD is founder and principal consultant at Evera Regulatory Advisors and brings over 20 years of experience in the medical device and life sciences field. Prior to founding Evera, Caroline served as the Global Business Lead for the North America medical device consulting team at NSF Health Sciences where she oversaw the regulatory, QMS, and audit workstreams. Dr. Rhim brings deep knowledge of the medical device regulations from her time as a
Branch Chief in the former Division of Orthopedic Devices at the Center for Devices and Radiological Health (CDRH), and as a lead scientific reviewer in both the Division of Orthopedic Devices and Division of Cardiovascular Devices. During her tenure at FDA, she was involved in streamlining the premarket and postmarket review process, as well as the classification efforts for posterior cervical screw systems. Dr. Rhim received her doctorate degree in Biomedical Engineering from Duke University, and her Bachelor and Master of Science degrees in Materials Science and Engineering from M.I.T.

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