Merav Shefer, Practical Engineer, ICQE

Quality & Regulatory Project Manager

Merav Shefer has 10 years of experience in Quality, Validation and Regulatory Affairs of Medical Devices, with specialty in product V&V.

During her previous position at MIS Implants Technologies, Merav has led the validation field throughout a vast range & disciplines – New Machine/Equipment; Cleaning; Sterilization; Package integrity & Shelf life and Process Validations. Writing validations SOPs, VMPs, IQ, OQ & PQ, Protocols & Final reports.

In the Regulatory field, she acquired great knowledge and practice in monitoring R&D projects, Design Controls, creation & implementation of risk management, OBL, supporting the marketing team with regulatory issues (including labelling and instructions for use), Biocompatibility and preparing submission documentations for CE, FDA, TGA and AMAR.

Merav is a Quality Engineer, certified by Israeli Society for Quality practical engineer in Biotechnology graduate at Ort Braude, Carmiel, Israel. Merav holds a lead auditor certificate from the IIS (ISO9001, ISO13458)

As a part of her work at Gsap Merav lead Projects at the following companies: Equashield Medical, Biosense Webster, NanoSpun Technologies, Hanita Lenses, Mérieux NutriSciences (Milouda& Migal Laboratories), DIR technologies, Syqe Medical, Ivory Graft, Inspire MD, MedyMatch, Ossio and G&G Biotechnologies.

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