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Invitation Only
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Repeat Solutions Circle
Repeat Solutions Circle

Kimberly A. Trautman, MS

Expert
RAPS BoD

Kimberly A. Trautman is an experienced Medical Device, InVitro Diagnostics, and Combination Product Expert with over 40 years of experience. Currently, Kim is on the RAPS Board of Directors. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Kim has industry experience, regulatory agency experience, as well as consulting expereince. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes 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.

Expert in global medical device regulations, she wrote and harmonized the current US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception. At FDA was also on the authoring group for 21 CFR Part 4 Combination Product GMPS. 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). Recognized International Medical Device expert with a Master's Degree in Biomedical Engineering.

EDUCATION
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

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