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Semih Oktay, PhD

President
Cardiomed Device Consultants
Annapolis, Maryland, United States

Prior to founding the CardioMed Device Consultants, LLC, Dr. Oktay worked for six years as an expert mechanical engineer and scientific reviewer for the U.S. Food and Drug Administration (FDA) and its Office of Device Evaluation, Center for Devices and Radiological Health, Division of Cardiovascular and Respiratory Devices, and Interventional Cardiac Devices Branch. He has extensive expertise in coronary stents, drug eluting stents, DEBs, balloon angioplasty and its effects on coronary arteries. Other areas of expertise include medical device and combination products regulatory requirements, device evaluation, and material science. Dr. Oktay received his Ph.D. degree in Mechanical Engineering from the University of Maryland in 1993.

Disclosure(s): Medical Device Manufacturers: I am a regulatory consultant to many cardiovascular device manufacturers (Ongoing)

Presentation(s):

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