Ted HeiseVice President Regulatory and Clinical Services, ISO TC/194 Member at MED Institute
Theodore (Ted) Heise has over 25 years of experience in regulatory and clinical affairs, and currently serves as Vice President Regulatory & Clinical Services at MED Institute. In this capacity, Dr. Heise leads efforts to develop scientifically robust regulatory and clinical study strategies for the company’s clients: entrepreneurs, consultants and developers bringing new medical products through the complex steps of the development process.
Graduating Magna Cum Laude with a B.S. in chemistry from the University of Nebraska at Omaha, Dr. Heise went on to earn a Ph.D. in analytical chemistry from Iowa State University. He has been a member of the Regulatory Affairs Professionals Society since 1993, and the American Chemical Society since 1988.
For the past 12 years Dr. Heise has been a U.S. delegate to ISO TC 194, the technical committee for international consensus standards that govern biocompatibility testing and clinical investigations of medical devices. He currently serves as convenor of TC 194/WG 14. As convenor, Dr. Heise led the process of re-writing ISO 10993-18 to reflect current best practices in chemical characterization, including evaluation of extractables and leachables.