Michael C. Morton

Founder

Michael C. Morton is an experienced medical device regulatory consultant. His most recent industry role was Vice President for Corporate Regulatory Affairs, at Medtronic, Inc., where he was responsible for public health policy advocacy in regulatory affairs, and for internal regulatory policy. 

Michael has over thirty years of experience in the medical device industry, including quality, clinical, and regulatory affairs.  Before joining Medtronic, Inc., Michael worked for CarboMedics, Inc.; W.L. Gore and Associates; Alcon Labs; and Sorin Group.  

Michael has been recognized as a Fellow, and is a member of the Board of Directors of the Regulatory Affairs Professional Society (RAPS).  He has been active in industry groups, including the Advanced Medical Technology Association (AdvaMed).  He chaired the AdvaMed PMA Working Group, and the Pediatric Devices Working Group, and was active in other technical and policy committees.  Michael represented industry within Study Group 1 (Premarket) of the Global Harmonization Task Force and has been active in the International Medical Device Regulators Forum and other harmonization organizations. 

Given Michael’s understanding of the medical device industry in the global economy, his primary interest has been device regulation in the United States.  As part of his work, Michael has helped to draft legislative language for the various amendments to the Food Drug and Cosmetic Act. He has helped to draft FDA guidance documents, and he has provided comments to the public docket on guidance and on proposed and final rules.  

Michael has viewed the FDA as a partner rather than an opponent in the legal process of bringing medical technology to market.  Consequently, he has been invited to provide training to the FDA through in-house courses sponsored by the Food and Drug Law Institute, to train new advisory committee voting members, and to participate in numerous workshops and other fora with FDA staffers. 

Michael served as the industry representative to the FDA Circulatory System Devices Advisory Panel.  He received an FDA service award for that work.