Gokhan Ozalp brings over 18 years of medical device Quality Systems Regulation experience to each client engagement, employing his extensive expertise in submission content, regulatory classifications, risk management of software-driven products and quality systems development, implementation and management.
Gokhan is responsible for over 20 FDA 510(k) clearances across a wide spectrum of medical devices. He has been involved in medical systems, varying from Class I through III. Gokhan has extensive experience interacting with FDA.
Gokhan holds a BS degree in Chemistry, Master of Science degree in Computers and Information Systems and Master of Business Administration degree with a Specialization in International Business. Gokhan attended seminars offered by Nancy Leveson in MIT on risk analysis of safety critical systems. He is a certified Project Management Professional.