Robert Ruff has over 35 years of experience in the medical device and public health sectors. Prior to joining NSF International, Rob worked in the orthopaedic device industry and had a distinguished career with the U.S. FDA. As an FDA Medical Device Specialist, he conducted inspections and investigations of a wide range of device technologies and co-developed the FDA Office of Regulatory Affairs (ORA’s) Level II medical device investigator certification programme. Rob was a primary instructor for ORA’s Basic Medical Device and Process Validation courses. He also developed several FDA e-Learning courses, including the Quality System Inspection Technique (QSIT), the Quality System Regulation and the Medical Device Reporting Regulation. From ORA, Rob joined the FDA’s Centre for Devices and Radiological Health to lead an international team tasked with the development, implementation and maintenance of the Medical Device Single Audit Programme (MDSAP). He co-authored the Quality System Inspection Technique and the MDSAP Audit Approach. Since joining NSF International in 2017, Rob has developed and taught courses on auditing against the EU MDR and EU IVDR (including the development of EU MDR and EU IVDR Audit Approaches), FDA inspection readiness, risk management, design controls, MDSAP, and many other topics. He continues to conduct audits against a variety of audit criteria, including the EU MDR and EU IVDR. Rob has also served as an FDA fact witness and, more recently, as an expert witness.
Read Some of Rob's Papers
10 Steps to Effective FDA 483 Responses: Medical Devices
Key FDA Policies, Procedures and Practices Before, During and After Medical Device Manufacturer Inspections
Insights and Expertise
White Paper: Tools and Tips for Writing Effective Nonconformity Statements During Quality Management System Audits of Medical Device Manufacturers