About

Michael Wienholt is the Principal Consultant at Regulatory Consulting. Michael is RAC certified in both United States and European Union regulatory affairs by the Regulatory Affairs Professionals Society, of which he has been a member since 1997. Michael spent 20 years in the medical devices and diagnostics industries in various roles, including product development, manufacturing, quality and regulatory affairs. Michael has over 9 years of direct experience in a regulatory affairs role in FDA-regulated industry. Michael is knowledgeable of the regulatory requirements for devices and diagnostics in the major OUS markets, and has obtained market clearances in a number of foreign countries. He is a member of the American Society for Quality (ASQ) and is an ANSI/RAB-accredited auditor of quality systems for the medical device industry.