Racheli Itayev is a QA/RA Expert with extensive experience in supporting health technology and software companies in compliance with regulatory standards. Currently at Physio-Logic Ltd. since July 2021, Racheli is involved in MDR and MDSAP transitions, as well as QMS certification to ISO 13485:2016 and FDA’s QSR. Previous roles include Quality Assurance Engineer at Pluristem Therapeutics and keystone Heart Ltd., where Racheli focused on implementing EU Medical Device Regulations, maintaining quality management systems, conducting audits, and managing training programs. Racheli holds a B.Sc. in Biotechnology from Tel-Hai College, obtained between October 2004 and July 2006.
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