Quality Assurance & Regulatory Affairs Expert for products and companies primarily related to medical devices and telecom that meet the real needs of their clientele. Substantial experience gained in various
multi-discipline technology industries
(Military, Telecom & Medical Devices), and give a
high-value contribution to quality and reliability projects related to the medical device and telecom industries.
More than 20 years of experience in QA; including MD&D RA & QA (EU-MDD/MDR, 510k);QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH&S Systems; QA/RA representative in R&D Projects; Risk Analysis as per ISO14791& ISO31000; EMC & Safety Certifications
Supply Chain QA & Supplier QA; CAPA; Training; Six Sigma; Process Validation; 5S and Lean Production; Configuration Control.
Orcanos provides an integrated Design Control (ALM) with a quality management system and regulatory compliance in a central repository. QWV accompanies the successful implementation of the system.
L.S. Marketing & Registration provides Israeli MoH Medical Devices Registration.
QWV with L.S. will provide you the best solution to enter the Israeli Medical Devices Industry.
QWV is a partner for eQMS/ALM solutions – making it easy for your company’s crew to establish, implement and maintain a viable “paper-less” Quality Management System that supports the pathway to Regulatory Approvals.
2010 - MBA, Technion, Israel
2001 - M.Sc., Quality Assurance & Product Reliability, Technion, Israel
1993 - B.Sc., Mechanical Engineering, Technion, Israel
2021 - IVDR, NSF
2021 - MDSAP Lead Auditor, NSF
2020 - ISO9001: 2015 Lead Auditor, Israel Institute of Standards
2019 - ISO13485: 2016 Lead Auditor, Israel Institute of Standards
2019 - Implementation of the Medical Device Regulation (MDR) for CE Marking Training, BSI
2019 - EU MDR (745/2017), MedicSense
2018 - ISO13485: 2016 Lead Auditor, BSI
2018 - Sterilization Processes, MedicSense
2017 - ISO27001 Lead Auditor, SII
2006 - 6Sigma Black Belt, J&J
2005 - 6Sigma Design Excellence, J&J
2005 - EMC & Medical Devices Safety (IEC60601-1), Aspect
2000 - Radiation Safety Officer
1998 - QA Lead Auditor, IDF
1997 - ICQE, ISQ
1997 - QA Systems Auditor, IDF