Executive Vice President

PROSYSTEM, an NSF International Company

Oliver Christ has been active in international standardization efforts for more than 25 years and co-founded PROSYSTEM with the late Dr. Jürgen Stettin in 1999. The company was acquired by NSF International in 2017. In Germany, Mr. Christ has served as chair or co-chair of national committees including Human Factors/Usability for Medical Devices, Risk-Management for Medical Electrical Equipment, and Software for Medical Devices and Networked Medical Systems. Mr. Christ represents Germany on international standard committees for programmable electrical medical systems, human factors, risk management, software life cycle processes, and risk management for IT-networks incorporating medical devices (published as IEC 80001-1:2010). In 2013 Mr. Christ became an international delegate for Germany for the AAMI/UL initiative UL 2800 on Interoperability for Medical Devices. He received the DKE Needle award in 2014.

Executive Vice President, Medical Device International Services

NSF International

Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. She is focused on expanding international regulatory affairs and compliance services for NSF’s medical device clients, including expanding medical device training services worldwide and spearheading the development of an independent, third-party regulatory certification program.

Ms. Trautman was previously Associate Director for International Affairs in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) where she led the CDRH’s international efforts and initiatives. She was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996. She also developed and implemented the extensive quality system regulation roll out and training programs, and led continuing harmonization efforts with ISO 13485.