Racheli Itayev is a seasoned QA/RA expert with extensive experience in the medical technology sector. Currently at Physio-Logic Ltd. since July 2021, Racheli supports health technology and software companies, focusing on MDR and MDSAP transitions, and has worked on QMS certification to ISO 13485:2016 and the FDA’s QSR. Racheli’s previous roles include quality assurance engineer positions at Pluristem Therapeutics and Keystone Heart Ltd., where responsibilities included implementing the EU Medical Device Regulation, QMS maintenance, supplier control, and conducting internal and supplier audits. Racheli holds a B.Sc. in Biotechnology from Tel-Hai College, earned between October 2004 and July 2006.
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