Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. Her experience includes leading international initiatives for the U.S. FDA to include the conception and development of the International Medical Device Single Audit Program. She was also responsible for writing the current U.S. FDA Medical Device Quality System (QS) regulation, 21 CFR 820, and leading the implementation, rollout and training associated with the QS regulation. She also led continuing harmonization efforts for ISO 13485 since its inception in 1994, where she is an international delegate to ISO/TC 210, author of ISO 13485, and the U.S. Technical Advisory Group co-chair for ISO/TC 210.