Center for Devices and Radiological Health

Center for Devices and Radiological Health
FDA''s Medical Device GMP/Quality Systems Expert
Office of Compliance, HFZ-340
Center for Devices and Radiological Health
U.S. Food and Drug Administration
2098 Gaither Road
Rockville, MD 20850
Kimberly A. Trautman is FDA’s Expert on Medical Device GMPs and Quality Systems. She was responsible for writing the final Quality System regulation and preamble published in 1996. Ms. Trautman was also responsible for the development and implementation of the extensive Quality System regulation Roll-Out and training programs. She reviews inspection reports of foreign and domestic medical device manufacturers to identify violations of the Good Manufacturing Practice (GMP) requirements, and provides GMP guidance to FDA field investigators and the medical device industry. Ms. Trautman provides GMP expertise to CDRH for various legal actions and regulatory reviews.

Ms. Trautman is the chair person for the Global Harmonization Task Force (GHTF)- Study Group 3, and has been a member of GHTF since 1993. Ms. Trautman is a US delegate for ISO/TC210, "Quality Management and Corresponding General Aspect of Medical Devices" Working Group 1 and is the US TAG co-chair for Working Group #1. Ms. Trautman is also a representative to the US TAG to ISO/TC176, "Quality Management and Quality Assurance."

Ms. Trautman has given lectures at medical device training courses for FDA field investigators, DSMA GMP workshops, HIMA conferences, RAPS conferences, FDLI workshops, ASQ/FDA Biomedical Industry Update Seminars, and many others. Prior to her current position, she was a patent examiner with the Patent and Trademark Office, specializing in medical devices.

Ms. Trautman received her Bachelor of Science degree in Molecular and Cell Biology from The Pennsylvania State University, University Park, Pennsylvania, and a Masters of Science degree in Biomedical Engineering from The University of Virginia, Charlottesville, Virginia. She is a member of the American Society for Quality (ASQ) and the Association for the Advancement of Medical Instrumentation (AAMI).