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 7 years in executive RA & Clinical management positions at Medtronic.

She holds a Master’s degree in Biomedical Engineering from the Technion (Haifa, Israel) and has practical experience in the medical device development process, risk management, addressing user and business needs, as well as understanding clinical environments.

Ms. Givony specializes in innovative regulatory strategy, FDA premarket submissions, compiling the Technical File binder for CE marking, and managing clinical study planning, the approval process, and execution.

With extensive experience in written interactions and meetings with the FDA and Notified Bodies, she has successfully led efforts that resulted in creative, less burdensome solutions, successful submissions, and marketing clearances—always taking broader business aspects into account.