Semih H. Oktay PhD

Dr. Semih Oktay is the President and founder of CardioMed Device Consultants. Prior to founding CardioMed, 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, where he served as primary reviewer in the product areas of coronary stents, peripheral stents, and balloon angioplasty catheters. While at FDA, he represented the Agency at numerous panel advisory meetings, scientific symposia, policy conferences, and voluntary standards development organization meetings.

Dr. Oktay holds a considerable, in-depth understanding of the fields of material science, medical devices, medical device regulations, and regulatory submission requirements. He has extensive experience interpreting and evaluating engineering data, developing and presenting reports of scientific review, and devising and modifying guidelines and protocols for the testing of medical devices.