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Kimberly A. Trautman, MS

Managing Director and Vice President
MEDIcept

Kimberly A. Trautman is an experienced Medical Devices, InVitro Diagnostics, and Combination Product Expert with over 30 years of experience. Kim is currently the Managing Director and VP at MEDIcept, Inc. She worked at the US Food and Drug Administration (FDA) for 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 medical device and combination product 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, wrote and harmonized the current US FDA Quality System Regulation and has been on the international authoring group TC 210 Working Group 1 for ISO 13485 since inception in 1994 to present. Expert in combination products and was on the FDA authoring committee for 21 CFR Part 4 and FDA Combination Product GMP guidance documents. Member of the ASTM E55 Combination Product Definitions standard. 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 expert.
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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