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# Trautman Leaves FDA to Join Consulting Company
- URL: https://www.fdaweb.com/trautman-leaves-fda-to-join-consulting-company/
- Published: 2016-01-26T12:00:00.000Z
- Updated: 2026-09-15T02:30:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134560

> After a 24-year career at FDA, CDRH associate director for international affairs **Kim Trautman** has retired and joined consulting group NSF International Medical Devices as executive vice president of international regulatory compliance services. Trautman is described as an expert in medical device quality systems and international regulatory affairs. At NSF International, she will work to expand international regulatory affairs and compliance services for its medical device clients. “This includes expanding current U.S. and European medical device training services internationally, and spearheading the development of an independent, third-party regulatory certification program,” the company says.  
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> At CDRH, according to NSF International, she led the Center’s international efforts and initiatives, which included coordinating the Center’s Medical Device Single Audit Program, the Harmonization by Doing initiatives, bilateral and multilateral programs, exchanges with foreign regulators and many other international activities. She was responsible for writing the current Quality System Regulation (QSR) and preamble published in 1996\. She also led harmonization efforts with ISO 13485, which includes the most recent version of ISO 13485 that will be published later this year.  
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> However, Trautman’s time at FDA was not without controversy. At CDRH she was often to be found addressing industry meetings on QSR compliance, a role that frequently led to criticism of her “prescriptive” instruction on guidances, which are advisory only. This approach [came to a head in 2005](http://www.fdaweb.com/login.php?sa=v&aid=D5101309&searchWords=Kim%20Trautman&cate=S&stid=%241%24UO3.N73.%24jzb6BOBoakk.NeagD%2FhTW0), when she was faulted in federal court documents for allegedly prescribing from headquarters how Form FDA-483s and Establishment Inspection Reports should be written up in a Utah inspection that led to an historic FDA defeat. Although it failed to appeal the decision, FDA management at multiple levels stood by Trautman.