Robert (Rob) Ruff

Executive Director

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 orthopedic 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 codeveloped the FDA Office of Regulatory Affairs (ORA’s) Level II medical device investigator certification program. Rob was a primary instructor for ORA’s Basic Medical Device and Process Validation courses. He also developed several FDA eLearning 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 Center for Devices and Radiological Health to lead an international team tasked with the development, implementation and maintenance of the Medical Device Single Audit Program (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

Well documented FDA 483 observations can support FDA official actions. An effective and timely response to FDA 483 observations may help your organization avoid such actions.

Key FDA Policies, Procedures and Practices Before, During and After Medical Device Manufacturer Inspections

This paper by expert Rob Ruff provides a behind-the-scenes look at how FDA medical device inspections are planned, conducted and managed.

White Paper: Tools and Tips for Writing Effective Nonconformity Statements During Quality Management System Audits of Medical Device Manufacturers

As a medical device quality management system auditor, one of the most important (if not the most important) responsibilities of your role is to effectively communicate identified nonconformities to the auditee organization.