Vernon Baker is a Mechanical Engineer and Senior Medical Device Guru with over a decade of experience in medical device quality, regulatory affairs, and product development. Formerly the Director of Engineering for a successful Class III (PMA) medical device manufacturer in the USA, Vernon brings deep expertise in navigating complex regulatory landscapes. He is a certified ISO 13485:2016 Lead Auditor, a certified EU MDR Auditor, and a Regulatory Affairs Certified (RAC-Devices) professional. Passionate about applying first principles to regulatory challenges, Vernon specializes in translating compliance requirements into practical, effective solutions that drive innovation and market success.