Gokhan Ozalp

Gokhan Ozalp

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.