Trautman brings to NSF over 30 years of international regulatory affairs and compliance experience from the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH)

ANN ARBOR, Mich. — NSF International, a leading provider of regulatory compliance, quality systems, analytical testing, education and consulting services for the medical device sector, has appointed Kim Trautman Executive Vice President of International Regulatory Compliance Services for the NSF International Medical Devices group, part of the global NSF Health Sciences Division. She will be based in Washington, D.C.

Trautman is an expert in medical device quality systems and international regulatory affairs, and brings over 30 years of U.S. FDA experience to NSF International. In her new role, she’ll leverage her experience to expand international regulatory affairs and compliance services for NSF International’s 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.

At the U.S. Food and Drug Administration, Trautman served as the Associate Director for International Affairs in the Office of the Center Director at the Center for Devices and Radiological Health (CDRH). In that position, she led the CDRH’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.

Trautman was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996. She also developed and implemented the extensive quality system regulation roll out and training programs, and led continuing harmonization efforts with ISO 13485, which includes the most recent version of ISO 13485 which will be published later in 2016.

“Kim brings a wealth of regulatory and medical device expertise to NSF International from her previous role with the U.S. FDA,” says Elaine Messa, RAC, FRAPS, President of NSF Health Sciences Medical Devices. “Her experience and knowledge of FDA quality system regulations, as well as of the international regulatory environment and initiatives, will strengthen our global service offerings in the medical device area.”

Trautman served on the International Medical Device Regulators Forum (IMDRF) Management Committee and chaired the IMDRF Medical Device Single Audit Program Working Group. She was the chairperson for the Global Harmonization Task Force (GHTF) Study Group 3 from 1996 to 2005, and has been a member of GHTF since 1993. She is a U.S. delegate for ISO/TC210, Quality Management and Corresponding General Aspect of Medical Devices Working Group 1 and is the U.S. TAG co-chair for Working Group 1, the authoring group for ISO 13485. She is also a representative to the U.S. TAG to ISO/TC176, Quality Management and Quality Assurance, the authoring group for the ISO 9000 series of standards. She was also a member of the FDA Combination Productions GMP Working Group.

Additionally, Trautman was a member of the Steering Committee for the Center for Drugs’ GMPs for the 21st Century Initiative and co-chaired one of the working groups on quality systems. She also helped draft the U.S. FDA Combination Product GMP Final Rule. She has given lectures at medical device training courses for FDA field investigators, DSMICA GMP workshops, AdvaMed conferences, RAPS conferences, FDLI workshops, ASQ/FDA biomedical industry update seminars and many others.

Earlier in her career, Trautman worked at a medical device manufacturer in quality assurance and manufacturing, as a Captain in the U.S. Army serving as an Executive Officer for a medical company, and as a biotechnology patent examiner at the U.S. Patent and Trademark Office. She has a B.S. in molecular and cell biology from The Pennsylvania State University and an M.S. in biomedical engineering from the University of Virginia.

For more information about NSF International medical device services, please contact Chau Agon at hs@nsf.org or call +1 202-822-1844.

Editor’s note: To schedule an interview with an NSF International medical device expert, please contact media@nsf.org or call +1 734 214 6242.

About NSF International: NSF International is an independent global organization that writes standards, and tests and certifies products for the building materials, food, water, health sciences and consumer goods industries to minimize adverse health effects and protect the environment (nsf.org). Operating in more than 165 countries, NSF International is accredited by the American National Standards Institute (ANSI) and is a Pan American Health Organization/World Health Organization Collaborating Center on Food Safety, Water Quality and Indoor Environment. The NSF Health Sciences Division, which includes NSF Medical Devices, offers training and education, consulting, auditing, GMP and GLP testing, DNA testing, certification, R&D and regulatory guidance for the pharmaceutical, medical device, dietary supplement and bottled water/beverage industries throughout the product life cycle.