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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Michael Morton, FRAPS, RAC, began his career in the medical device industry in 1985, starting in the quality assurance function, and then moving into regulatory affairs. Michael has spent his career in the private sector and has worked for CarboMedics; W. L. Gore; Alcon; and the Sorin Group. Michael spent the last significant portion of his career in the corporate regulatory organization of Medtronic. He now works as an independent regulatory consultant.
Michael joined RAPS in 1989 and attended his first annual conference that year. He earned his RAC certification in 1991 and was recognized as a RAPS Fellow in 2008. Michael served on the RAPS Board of Directors from 2016-2019.
During his career, Michael has enjoyed helping to bring new medical technology to the patient community and to the market. He has an interest in higher risk devices, and has a special appreciation for the US FDA advisory committee process. Michael served from 2001-2005 as the industry representative to the Circulatory System Devices Panel. He is also interested in underserved populations and has supported several devices through the Humanitarian Device Exemption process.
Michael chaired the pediatric working group and the PMA working group as part of the Advanced Medical Technology Association (AdvaMed). He also represented US industry as part of Study Group 1 (Premarket) of the Global Harmonization Task Force. He serves as a regulatory reviewer for the Congressionally Directed Medical Research Program.
Michael has long been interested in education and, in Minnesota, supported the development of the regulatory affairs academic program at St. Cloud State University. Michael serves on advisory boards for the regulatory science programs at the University of Southern California and at George Washington University. He also serves on the advisory board for the Stephenson School of Biomedical Engineering at the University of Oklahoma
Michael lives in Colorado with his wife, Susan, and their two dogs. Both Michael and Susan are active in animal rescue.