Full Name
Michael Simpson
Professional Title
UDI Compliance Program Manager
Company
U.S. Food and Drug Administration
Speaker Biography
CDR Michael Simpson started his United States Public Health Service (USPHS) career performing facilities engineering with the Indian Health Service (IHS). Beginning in 2010 with the Tucson Area office, and then in 2011 at the California Area office. CDR Simpson was then commissioned in February 2013 with the Food and Drug Administration (FDA), becoming a second generation USPHS Officer. CDR Simpson’s first position was as a Medical Device Investigator where he accomplished over 75 routine and for-cause inspections of FDA regulated establishments and products, predominately medical devices that are located domestically and foreign. He then transferred to the Center for Devices and Radiological Health be an Engineer Reviewer and Regulatory Officer within OPEQ/DHT3C where he reviewed premarket applications and compliance to quality system regulations for infusion pumps, pen injectors, and general hospital devices. His current role is Compliance Project Manager of the Unique Device Identifier (UDI) Program within OPEQ’s Office of Regulatory Programs. In this role he assists firms with compliance to meet the regulatory requirements of the UDI Rule. In addition to CDR Simpson’s work with the FDA he has also performed five deployments with USPHS, most memorably being the Monrovia Medical Unit in Liberia during the Ebola epidemic and most recently being the Deputy OIC and Safety Officer for personnel deployed to aid unaccompanied minors and Afghan repatriates.
CDR Simpson is a graduate of the University of Maryland with a Master’s of Engineering in Project Management and a Bachelor’s of Science in Mechanical Engineering. He is a has been a member of the Society of American Military Engineers, Commissioned Officers Association, and American Society for Quality during his entire professional career and holds over 11 certifications. CDR Simpson and his wife, Laura, enjoy traveling when they aren’t busy with their sons, Logan (3) and Connor (1).
CDR Simpson is a graduate of the University of Maryland with a Master’s of Engineering in Project Management and a Bachelor’s of Science in Mechanical Engineering. He is a has been a member of the Society of American Military Engineers, Commissioned Officers Association, and American Society for Quality during his entire professional career and holds over 11 certifications. CDR Simpson and his wife, Laura, enjoy traveling when they aren’t busy with their sons, Logan (3) and Connor (1).
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