Zita Yurko

Zita Yurko has over 20+ years of experience in medical device regulatory affairs and quality systems. She was the VP of RA/QS at Harpoon Medical where she was responsible for securing ISO 13485 certification and CE mark for the company’s MDD Class III device. She has experience with FDA pre-submission meetings and supported the approval for all EU clinical sites where the Harpoon device was studied.