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Ted Heise
Vice 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.

Agenda Sessions

  • Guidance on the new ISO 10993 – 18 Highlighting the biggest differences between the old and new -18