Dr. Semih Oktay is the Founder and Chief Regulatory Officer of CardioMed Device Consultants, bringing more than 30 years of experience in medical device regulatory affairs, engineering, and product development. A former FDA scientific reviewer, he specializes in complex Class II and Class III devices, particularly cardiovascular and interventional technologies. His expertise in regulatory strategy, device testing, and FDA submissions has helped manufacturers navigate complex regulatory pathways and bring innovative medical technologies to market.
Experience
Dr. Oktay founded CardioMed in 2003 and has more than two decades of experience advising medical device manufacturers on regulatory strategy, preclinical testing, engineering evaluations, and FDA submissions.
Previously, he served as Vice President of Regulatory Affairs and Engineering at MicroMed Laboratories and spent six years as an FDA scientific reviewer in the Interventional Cardiology Devices Branch, evaluating coronary and peripheral stents, angioplasty catheters, and related technologies. He represented FDA at advisory panel meetings, scientific conferences, and standards development activities.
Dr. Oktay also served as an Adjunct Assistant Professor at the University of Maryland, Baltimore County, and received multiple FDA recognition awards.