BIO

Medical Device, IVD and Combo Product Expert

Kim Trautman, former Associate Director of International Affairs at FDA, is an experienced medical device, IVD, and combination product expert with over 30 years of industry and regulatory agency experience. An expert in global medical device regulations, she wrote and harmonized the current FDA Quality System Regulation. Trautman was also on the FDA authoring committee for 21 CFR Part 4 and FDA Combination Product GMP guidance documents. In addition, she developed the International Medical Device Single Audit Program (MDSAP) and consortium from conception through its pilot. Trautman is a 25-year veteran of the Global Harmonization Tasks Force (GHTF) and a foundational member of the International Medical Device Regulators Forum (IMDRF).