Barry Camrell, Myomo’s Vice President – QA/RA, is a medical device professional having 25+ years of cross-functional experience as Consultant, Engineer and Manager having extensive capabilities in: Quality and Compliance, Regulatory Affairs (US and OUS), Manufacturing and Industrial Engineering, Operations Management, and with the overall product realization process. Extensive experience in developing Quality Systems, QAE, Design Controls, leading product acquisitions and transfers from development into manufacturing and production, Process Validation, Design V&V, and Supplier Qualification. A leader and Director for strategic outsourcing and certification of contract manufacturers, including qualifying part suppliers to produce commercial product. Formally trained and qualified in cGMP, Project Management, Auditing, Design V&V and Process Validation. Possess compliance and risk management expertise with FDA Regulations 21 CFR 820, 803, 806, ISO13485, 14971, and the MDD and new MDR.
