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NSF Adds Former U.S. Regulator to Medical Device Certification and Training Program

Robert Ruff joins NSF as Executive Director, Medical Device Certification and Training

ANN ARBOR, Mich. - NSF, a global public health organization and leading provider of regulatory compliance, quality systems, analytical testing, education and consulting services for the medical device sector, has appointed U.S. Food and Drug Administration (FDA) veteran Robert Ruff to the post of Executive Director, Medical Device Certification and Training.

In his new role, Ruff will provide NSF’s medical device industry clients with expert training and certification services. His primary responsibilities will be to manage key sectors of NSF’s global medical device business and to use his expertise and resources in meeting the needs of clients.

“Rob brings the utmost integrity and dedication to NSF,” said Kim Trautman, Executive VP for International Medical Device Services at NSF. “With his diplomatic manner, extensive knowledge and unique expertise, he accomplishes difficult projects while maintaining collaborative working relationships with colleagues and customers alike. We are thrilled to welcome him aboard.”

Ruff brings over 30 years of experience in the medical device and public health sectors to NSF. After serving in the United States Army, Ruff began his career in the orthopedic industry. From there he went on to a distinguished career at the United States Food and Drug Administration (FDA), where he spent 27 years in various roles, beginning as an investigator for the New Jersey District Office.

At the FDA, Ruff was a member of the Office of Regulatory Affairs (ORA) Medical Device Investigator Certification Board, where he assisted in the development and management of ORA’s Level II medical device investigator certification program. Ruff later moved to the FDA’s Center for Devices and Radiological Health, where he led an international team of subject matter experts tasked with the development, implementation and maintenance of the Medical Device Single Audit Program (MDSAP).

Throughout his career, Ruff has been extensively published, authoring or co-authoring regulatory audit models (including Quality System Inspection Technique (QSIT) and the MDSAP Audit Model), training programs, courses and articles. He has been the recipient of a variety of awards, including the FDA Distinguished Career Service Award, FDA Award of Merit, Commissioner’s Special Citation, FDA Outstanding Achievement Award and the Leveraging/Collaboration Award.

NSF is a global, independent organization that writes standards, and tests and certifies products for the health sciences, water, food and consumer goods industries to minimize adverse health effects and protect the environment. Founded in 1944, NSF is committed to protecting human health and safety worldwide. With clients in more than 170 countries, NSF is a Pan American Health Organization/World Health Organization (WHO) Collaborating Center on Food Safety, Water Quality and Indoor Environment.

NSF’s health sciences services include training and education, consulting, auditing, GMP and GLP analytical testing, DNA testing, certification, R&D, regulatory guidance and corporate compliance for the pharma biotech, medical device, dietary supplement and bottled water/beverage industries throughout the product lifecycle. NSF wrote the only American National Standard (NSF/ANSI 173) that verifies the health and safety of dietary supplements and also tests and certifies products to this standard.

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