Ilan Goldberg
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Organization / Workplace
Physio-logic Ltd.Location
Israel IsraelOccupation
Sr. QA/RA Expert at Physio-logic Ltd.About
Over 20 years of extensive experience in the medical devices industry including managing quality and regulatory affairs departments in both well-established and start-up companies. In-depth experience with implementing quality management systems (QMS) in start-up companies, ISO 13485 and Quality System Regulation 21 CFR 820, Creating a Global Regulatory Affairs Strategy, Submit Technical File for CE certification, Submit application for TFDA in Taiwan, Submit application to Ministry of Health and Family Welfare (MHFW)-Government of India, Registering with AMAR the Israeli Ministry of Health’s medical device regulation unit, Creating Technical File for FDA 510k submission, Submit applicati...