March 11-12, 2019,  Hyatt Regency San Antonio Riverwalk, San Antonio, TX USA

The World’s Leading Conference on ISO 9001 & Related Standards


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.

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A Step-by-Step Guide to ISO 9001:2015 Transition

ISO 9001:2015
Management Training

“ISO 9001 is used by millions of people and organisations around the world and the upcoming 2015 revision will have a big impact on those who work with the standard.

The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, training organisations, implementing organisations, procurement organisations, consultants and customers.”

An excerpt from IRCA Resources on “ISO 9001: IRCA Supporting the 2015 Revision”, October 2013