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shay_lsb

Shay Leventhal Gabay

Sep 15, 11:45|Teva Hall

Shortening Medical Device Time to Market: How to Expedite the Regulatory Clearance

QA/RA Project Manager, Medical Device at Gsap Ltd.

Over the years Ms. Leventhal-Gabay has gained vast regulatory experience in both the pharmaceutical and the medical device industries including diverse regulatory strategies for "startup" companies, FDA 510(k), CE, Health Canada, TGA and AMAR submissions. In addition, she has great understanding and practice in monitoring R&D projects and device validations, implementation of risk management procedure, writing design history files and technical files as well as reviewing software documentation, pre-clinical and technical data and supporting the marketing team with regulatory issues (including labelling and instructions for use).

Holds Bachelor’s degree (BSc) from the Hebrew University in Jerusalem in Psychobiology (Psychology and Biology) and a Master’s degree (MSc) in Biochemistry from the Weizmann Institute of Science.

Within her role In GSAP, Ms. Leventhal-Gabay leads QA and RA projects in the medical device industry (MDD, IVD and combination products).