Gerry Tal
Senior QARA consultant
Gerry Tal, B.Sc. Mechanical engineering, M.B.A. has experience of over 25 years in the medical devices companies. He served as VP R&D and QA / RA in several companies establishing and leading the QA and RA activities from initiation to product release to market.
His experience includes quality management systems implementation, representation in audits, leading the certification process with EU notified bodies, regulatory submissions and preparation of technical files for CE and FDA 510(k) submissions, MDR 2017/745 implementation and MDSAP implementation.
Mr. Tal is a certified auditor for ISO 13485:2016, MDSAP and ISO 9001:2015.
His background in R&D management allows support of design history files preparation, risk management process support and verification and validation activities.
