Who Should Attend
Unites States Medical Devices
Dr. Semih Oktay
President and Founder
CardioMed Device Consultants, LLC
Dr. Semih Oktay, former scientific reviewer at the U.S. Food and Drug Administration (FDA) and President and founder of CardioMed Device Consultants, LLC, will present this training seminar. Below is a synopsis of Dr. Oktay's credentials:
- Worked for six years as an expert mechanical engineer and scientific reviewer for the FDA in the Office of Device Evaluation, Interventional Cardiology Devices Branch;
- Served as primary reviewer in the product areas of coronary stents, peripheral stents, and balloon angioplasty catheters;
- Represented the Agency at numerous panel advisory meetings, scientific symposia, policy conferences, and voluntary standards development organization meetings;
- Provided consulting support and guidance in the areas of mechanical engineering, material science and medical device regulations to other FDA offices, U.S. governmental agencies, and international regulatory agencies;
- Received both individual and group recognition awards from the Agency;
- Experienced in 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;
- He is also an Adjunct Faculty at the University of Maryland Baltimore County and his research interests are in coronary stents, balloon angioplasty and the effects of balloon angioplasty on coronary arteries.