Quality / Regulatory
Michael is a hands-on technologist and strategist implementing and enhancing regulatory affairs, quality systems and clinical affairs for medical devices (including in-vitro diagnostic tests and diagnostic systems). He has been a lead regulatory and quality liaison responsible for developing and implementing key quality and regulatory functional strategies including obtaining complex approvals and clearances from the US FDA and international agencies. He has harmonized key quality & regulatory strategies and processes and has worked for several successful companies in the past including Thoratec and Evalve (now part of Abbott Cardiovascular), Crux Biomedical, Procept BioRobotics, Siris Medical and InterVenn Biosciences. Michael holds two bachelor’s degrees in Chemistry (Midwestern State University) and Mechanical Engineering (San Jose State University). He earned his MBA from St Mary’s College of California.