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BIOGRAPHY

Kimberly A. Trautman

Executive Vice President, Medical Device International Services, Washington, DC, USA

Ms. Kimberly A. Trautman is Executive Vice President for Medical Device International Services at NSF International, where she is focused on expanding international regulatory affairs and compliance services, including the expansion of NSF’s medical device training worldwide and developing an independent third-party regulatory certification program. 

Prior to joining NSF International, Ms. Trautman held the position of Associate Director for International Affairs in the U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH), and served as FDA’s most senior Medical Device International Quality Systems Expert. 

During her career with FDA/CDRH, she was instrumental in the development and implementation of the Medical Device Single Audit Program (MDSAP), Harmonization by Doing Initiatives, CDRH Bilateral and Multilateral programs and many other international activities. At FDA, she was an active member of the International Medical Device Regulators Forum (IMDRF) Management Committee and chaired the IMDRF MDSAP Working Group. 

Her work on the Global Harmonization Task Force (GHTF) Steering Committee, where she served as GHTF Study Group 3 Chairperson from 1996 to 2005, has resulted in many transformational global programs in place today. She continues to serve as a US delegate for the international standards committee, ISO/TC210 - Quality Management and Corresponding General Aspect of Medical Devices, and serves as an international expert and US Technical Advisory Group (TAG) co-Chair on ISO/TC 210 Working Group 1. 

Notably, Ms. Trautman was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996, and for the development and implementation of the extensive roll-out and associated training programs. In addition, she is responsible for the continuing harmonization efforts with ISO 13485 “Medical devices – Quality management systems – Requirements for regulatory purposes.” 

As a recognized quality systems expert and visionary for the Medical Device Single Audit Program, Ms. Trautman has given lectures and medical device training courses nationally and internationally for Foreign Regulators, FDA Investigators, and many industry leaders around the globe. 

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.

Participating Organizations at the ISO 9000 World Conference

Government Agencies

Department of Commerce
Department of Defense
Department of Energy
Department of Health & Human Svcs.
Department of Homeland Security
Department of Justice
Department of State
Department of the Treasury
Department of Transportation
Department of Veterans Affairs

Environmental Protection Agency
NASA
Naval Surface Warfare Center
Pentagon
U.S. Air Force
U.S. Army
U.S. Marine Corps
U.S. Navy
U.S. Veterans Affairs
United States Army Corps of Engineers

Corporations

AIG
Alcoa
AT&T
Bank of America Corp
BASF Corporation
Bayer Corporation
BMW
The Boeing Company
Bose Corporation
Bristol-Myers Squibb
Campbell Soup Company
Cardinal Health
Caterpillar
Chrysler Corporation
Chevron
Cisco Systems
Coca-Cola
Comcast
Daimler Chrysler
Disney
Dow Chemical

Dr Pepper 
Duracell
Dupont
Eastman Kodak
Facebook
Google
Exxon Mobil
Fedex
Ford Motor
General Electric 
General Motors
Gillette
Goodyear Tire
He
wlett Packard
Honeywell
Humana
IBM
Johnson & Johnson
Kohler
Lockheed Martin
Macy’s
M&M/Mars

ManpowerGroup
Maytag Appliances
Mercedes
Merck
Mitsubishi
Mobil Chemical
Motorola
NASA
Nestle 
Northrop Grumman
PepsiCo
Philip Morris International
PNC Financial Services Group
Pfizer
Pratt & Whitney
Procter & Gamble
Prudential
Raytheon
Rolls Royce Allison
Target

Schindler Elevator Corporation
Schneider Electric
Shell
Siemens
Southwest Airlines
Staples
Tesla
Tiffany & Co.
Qualcomm
Underwriter Laboratories
UnitedHealth Group
United Technologies
Union Pacific
UPS
USAA
Verizon
Walmart
Wells Fargo
Westinghouse
Whirlpool
Xerox

CONTACT US

Tel:  1 (408) 894-9910 or 1(800) 875-1960
Fax: 1 (866) 500-9081
Email: info@iso9000conference.com



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