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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.

Call for Proposals

Proposal Submission Deadline:
October 11, 2019

Acceptance notification date:
November 11, 2019

Early Registration Deadline:
February 11, 2020

Please make sure to review and prepare the material needed before you start the on-line Proposal Submission Form. Click here to see Proposal Submission Guidelines.

Who May Submit: This online form may be used by a principal speaker, co-speaker, contact person, or a committee member submitting on behalf of a speaker.

Multiple Proposals: You may submit multiple proposals.

Conference Registration Fee:
The conference registration fee is waived for the principal speaker of accepted proposals. Speakers are responsible for their travel expenses and arrangements. Co-speakers will receive a 20% discount for the conference that they are presenting at.

Length of Presentations: Technical sessions are typically 35 minutes. There will be a limited number of "double" sessions, 70 minutes, at the end of each day.


You will need the following to submit a proposal

Proposal Title: Maximum 80 characters including spaces. 

Keywords:Please include three keywords with a maximum of 100 characters, including spaces. 

Industry Sector: Please select the most relevant Industry sector for the proposal from a list.

Abstract: The Abstract should be 1,500 to 5,000 characters (note that it is Characters, NOT words), including spaces.

Biography: The Biography must be 1,500 to 5,000 characters, including spaces.

Public Profile: LinkedIn or Public Profile for link for the Principal Speaker: 

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(*) based on previous conference attendance





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