Over the past 25 plus years, Michael worked for major accredited testing laboratories and notified bodies certifying medical devices. His medical device experience include both non-active and active devices ranging from joint compression devices, surgical saws to rapid infusion pumps. Michael also worked for medical device R&D companies.
He was a mentor in Elemed’s Mentoring Program where he donated his time mentoring RA/QA professionals achieve their goals and develop their leadership skills.
He is actively working on several projects involving regulatory assessments for the US FDA, EU MDR, and UK MDR. His overall medical device regulatory experience span across multiple markets to include, US FDA 510k, CE marking under the MDR, UKCA marking, ASEAN Medical Device Directive, to name a few.