Kimberly A. Trautman, Global Expert Medical Device, IVD & Combination Products

KIM TRAUTMAN, M.S. is an experienced Medical Devices, InVitro Diagnostics, and Combination Product Expert with over 40 years of experience.

Kimberly A. Trautman is an experienced and recognized International 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. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes several strategic, quality and regulatory services. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.

Expert in global medical device regulations, wrote and harmonized the 1996 US FDA Quality System Regulation. Was on the international authoring group of ISO 13485 since inception and continues to date. Part of the FDA authoring group for 21 CFR Part 4 Combination Product GMPs and many of the Combination Product guidance documents. Conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF).