Managing Director and Vice President
Kim Trautman, former Associate Director of International Affairs at FDA, is an experienced medical device, IVD, and combination product expert with over 30 years of industry and regulatory agency experience.
As managing director and vice president, Kim is an integral part of the MEDIcept executive management team. She provides strategic client consulting services, develops business relationships with new clients, and leads the MEDIcept Training Immersion Program, developing the next generation of medical device consultants.
An expert in global medical device regulations, she wrote and harmonized the current FDA Quality System Regulation. Kim was also on the FDA authoring committee for 21 CFR Part 4 and FDA Combination Product GMP guidance documents. In addition, Kim developed the International Medical Device Single Audit Program (MDSAP) and consortium from conception through its pilot. She is a 25-year veteran of the Global Harmonization Tasks Force (GHTF) and a foundational member of the International Medical Device Regulators Forum (IMDRF).
After retiring from FDA, she established an Authorized MDSAP Auditing Organization and launched a new Notified Body for EU IVDR/MDR Designation. She currently serves on the Board of Directors at the Regulatory Affairs Professionals Society (RAPS), has been on TC 210 Working Group 1 for ISO 13485 since its 1994 inception, and is a member of the ASTM E55 Combination Product Definitions standard. Kim also serves as the College of Engineering Vice Chair for the Industry & Professional Advisory Council at Penn State.
FDA’s Shift from QSR to ISO 13485:2016: A Significant Change for Inspections