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Kim Trautman

Expert
Medical Device, IVD and Combo Product Expert

Kim Trautman, former Associate Director of International Affairs at FDA, 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).

Author or co-author:
Trautman, K (1997). The FDA and Worldwide Quality System Requirements: Guidebook for Medical Devices. Publisher: ASQC
Neadle, S. (editor: 2023). The Combination Products Handbook: A Practical Guide for Combination Products and Other Combined Use Systems. Publisher: CRC Press

M.S. of Biomedical & Medical Engineering, University of Virginia, Charlottesville, VA
B.Sc. of Molecular Cell Biology and Engineering Sciences, Pennsylvania State University, State College, PA

Disclosure information not submitted.

Presentation(s):