Kimberly A. Trautman is an expert in medical devices, in vitro diagnostics, and combination products, with over 40 years of experience. She worked at the U.S. Food and Drug Administration (FDA) for over 24 years and continues to work with regulatory agencies around the globe. Kim also possesses industry experience.

Kim is an expert in global medical device regulations. She authored and harmonized the 1996 U.S. FDA Quality System Regulation and has served on the international authoring group of ISO 13485 since its inception. While at FDA, she conceived and developed the Medical Device Single Audit Program (MDSAP) and its consortium of five Global Regulators. Kim was a twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and a founding member of the International Medical Device Regulators Forum (IMDRF).

Kim has a demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. She has executed several medical device regulatory services and developed a formal education/training business. She established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.

She has a Master’s in Biomedical Engineering.