ABOUT

About Dalia Givony

Ms. Givony is a regulatory and clinical affairs professional with 20 years of experience in global regulatory and clinical studies of medical devices including an executive RA & Clinical management positions for 7 years at Medtronic.

Ms. Givony holds master's degree of Biomedical Engineering from the Technion (Haifa, Israel) and has practical experience in medical device development process, risk management, user & business needs as well as clinical environments.

Specializing in innovative regulatory strategy, FDA premarket submissions, Technical File binder for CE mark, as well as clinical studies planning, approval process and execution.

Extensive experience with FDA/ Notified Body written interactions and meetings leading to creative, less burdensome resolutions, successful submissions and marketing clearance, while taking into consideration other business aspects.