Rob Ruff headshot

Robert Ruff

Executive Director, Medical Device Certification and Training

Medical Devices

North America

Robert (Rob) Ruff has over 30 years of experience in the medical device and public health sectors. Prior to joining NSF International, he worked in the orthopedic device manufacturing industry and completed a long, distinguished career with the U.S. FDA. Ruff was a district Medical Device Specialist and Senior Investigator in the FDA’s Office of Regulatory Affairs (ORA), where he conducted investigations for a broad range of device technologies. He was a member of the ORA Medical Device Investigator Certification Board, where he co-developed ORA’s Level II medical device investigator certification program. From ORA, Ruff was recruited by FDA’s Center for Devices and Radiological Health to lead an international team of subject matter experts tasked with the development, implementation and maintenance of the Medical Device Single Audit Program (MDSAP). His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.