Israel Citron is the Quality Assurance and Regulatory Affairs Executive at BrainsGate LTD. Recently gained CE certification for the ISS500 Ischemic Stroke system and the PMA currently is being reviewed by FDA. Israel Citron is an active member of IEC TC62A and ISO TC210 JWG1 that recently published ISO 14971:2019 and ISO TC 24971:2020 “Risk management for Medical Devices” Standard. Before Joining BrainsGate Israel Citron was VP Quality Assurance Regulatory Affairs and Clinical Affairs for 5 years and was responsible for all Regulatory Affairs and Quality Assurance activities related to all product lines of Aspect Imaging, Medical, Pre-Clinical and industrial applications of the company’s Compact High-performance MRI and NMR systems. The company is performing animal studies and clinical studies in Israel on its Medical MRI products. Before Joining Aspect Imaging Israel Citron was Senior Site QARA manager at GEHC in Israel for 8 years, with responsibility over the Cardiovascular Ultrasound systems developed and manufactured in Israel and with oversight on other GEHC sites in Israel and in Europe. Including involvement in clinical studies. Before re-joining GEHC Israel Citron was QARA Director at Biosense Webster Israel a J&J company for 4 years with specialty on cardiovascular EP mapping systems and Catheters. Prior to that Israel Citron was QARA manager at GEHC MRI operations which was acquired from Elscint. Israel Citron hold MSc and BSc in Electrical Engineering from the Technion MTI, and an MBA in Operations Research from Tel Aviv University Israel Citron is active member of IEC TC62B/MT40 and ISO TC210/WG1, JWG1, WG3.