Director of QA & RA at ScoutCam. B.Sc in pharmaceutical engineering and M.Sc in quality and reliability engineering. A certified quality manager (ICMQ) from the Israel Society for Quality (ISQ). Highly experienced in medical devices’ quality, including quality control and quality assurance. Experienced in working under ISO standards (9001, 13485), FDA (510(k) and reporting), MDD (CE mark, reporting). Ronen is a leader in internal audits plan, performing internal and external audits (at the vendors’ facilities), leading the notify body’s audits at ScoutCam’s. An experienced process validation and protocols director.