Kim Trautman

USC Kim Center Advisory Committee - Department of Regulatory and Quality Sciences

Kimberly A. Trautman is an experienced Medical Devices, InVitro Diagnostics, and Combination Product Expert with over 40 years of experience. She worked at the US Food and Drug Administration (FDA) for over 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience.

Kim is an expert in global medical device regulations, she authored and harmonized the 1996 US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception and still today. 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 foundational 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. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.

Recognized International Medical Device expert with a Master's Degree in Biomedical Engineering.

 

: kimtrautman