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Shimon Vaknin, RAC has extensive experience as a RA/QA Consultant in the medical devices industry. Shimon has worked with various companies including Exero Medical, NONAGON, CAPS Medical, Vigor Medical Technologies Ltd., PulmOne Advanced Medical Devices Ltd, DarioHealth, Eitan Medical, Check-Cap Ltd., and sensible. In addition to their consulting roles, they have also served as the CEO of QR Wise Ltd. Shimon'swork experience spans from 2018 to the present.

Shimon Vaknin received their Regulatory Affairs Certification (RAC) (US) from RAPS (Regulatory Affairs Certification Program) in 2015. Prior to that, they obtained a BA in Management & Social Science from Open University Israel, which they completed between 2008 and 2011. In 2008, they also acquired several certifications from The American Society for Quality, including CQA, CQE, and CMQ/OE. From 1994 to 1996, Shimon pursued a Software Practical Engineer degree from Handassaim (Technion, Haifa). Additionally, they gained expertise in Regulatory Medical Writing from the Regulatory Affair Professional Society's Online University. Furthermore, in November 2014, they became a member of RAPS.