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Dr Semih Oktay is the President and founder of CardioMed Device Consultants. Dr Oktay worked for six years as an expert Mechanical Engineer and scientific reviewer for the U.S. Food and Drug Administration (FDA) in the Office of Device Evaluation, Interventional Cardiology Devices Branch. In this role he served as primary reviewer in the product areas of coronary stents, peripheral stents, and balloon angioplasty catheters. Dr Oktay holds a considerable and in-depth understanding of the fields of material science, medical devices, medical device regulations, and regulatory submission requirements.