Amy Chan
Product Reviewer, GMED North America
Amy is a medical device professional with 15 years of extensive experience in the pharmaceutical and medical device fields. She has worked as an engineer in research and development, manufacturing, and quality assurance at renowned medical device companies. In these roles, she has served as a pivotal part in facilitating the market entry of innovative and life-saving medical devices. For the past 5 years, Amy has worked as a product reviewer at notified bodies specializing in the review of non-active cardiovascular devices. Amy is currently a product reviewer in Cardiology at GMED North America. Amy holds a Master’s degree in Bioengineering from University of California, San Diego.
Adam Barlett
Certification Project Manager and Product Reviewer, GMED North America
Adam is an expert in product development and risk management for orthopedic medical devices, with over 8 years of experience in end-to-end development for globally sold products. He has played a key role in developing implants and instruments for treating and reconstructing joints, addressing hip, knee, extremity, sports medicine, and trauma needs. As a Certification Project Manager at GMED North America, Adam guides clients through ISO 13485:2016, MDSAP, Medical Device Directive 93/42/EEC, and Medical Device Regulation 2017/745 audits and evaluations. He is also a qualified reviewer for non-active orthopedic implants and non-active, non-implantable instruments undergoing MDR evaluation.
