Our staff of former FDA and EU officials as well as Industry experts allows us to combine global regulatory knowledge with industry best practices to help our clients achieve a compliant quality system that is right for their business. Our team has extensive experience in the development, marketing, and international regulation of medical device products, and a proven record of achieving client success.
Kim Trautman, Executive Vice President, Medical Device International Services
Phone: + 1 202.822.1852
Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. Her experience includes leading international initiatives for the U.S. FDA to include the conception and development of the International Medical Device Single Audit Program. She was also responsible for writing the current U.S. FDA Medical Device Quality System (QS) regulation, 21 CFR 820, and leading the implementation, rollout and training associated with the QS regulation. She also led continuing harmonization efforts for ISO 13485 since its inception in 1994, where she is an international delegate to ISO/TC 210, author of ISO 13485, and the U.S. Technical Advisory Group co-chair for ISO/TC 210.
Heather Howell - Executive Vice President, Education and Communication Services
Phone: + 1 202.828.1594
Heather Howell has more than 25 years of U.S. Food and Drug Administration (FDA) experience developing communication strategies for high-risk safety issues and leading blended learning programs. At the U.S. FDA, Ms. Howell served as the Deputy Director, Office of Communication and Education in the Center for Devices and Radiological Health (CDRH), where she developed benefit-risk information and implemented a robust risk communication program. Ms. Howell works with the medical device industry to minimize patient risk by ensuring that client communication strategies are consistent with FDA directives and policies. She is expanding NSF’s current U.S. and European medical device training internationally, growing certification training programs and offering customized and innovative solutions to help companies comply with the ever-changing regulatory landscape.
James Pink - Executive Vice President, Consulting Services
Phone: +44 1142 541270
James Pink has over 20 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and non-active implantable and combination products. Mr. Pink is a contributor to several medical device standards committees including ISO 13485, ISO 14971 and various product-related standards.
Gunter Frey - Executive Director, Quality Systems
Phone: + 1 470.398.9873
Gunter Frey has nearly 30 years of experience in developing and implementing quality systems in the medical device industry. Mr. Frey has extensive experience in the manufacture of diverse medical devices and combination products including verification and validation activities, practical application of international standards, regulatory affairs, complaint handling and reporting, and corrective and preventive actions. His experience also includes guiding and executing remediation efforts and resolving complex compliance gaps for large international companies. As a member of Study Group 3 of the Global Harmonization Task Force, and various technical committees, Mr. Frey significantly contributed to the writing of international standards, such as ISO 13485, as well as guidance documen
Meaghan Bailey, RAC -Managing Director
Phone: + 1 202.822.1853
Meaghan Bailey’s expertise is in the analysis of complex regulatory challenges, and her consulting supports the development and compliant marketing of innovative medical devices. She advises life science companies on regulatory strategies, prepares regulatory submissions, conducts literature reviews and other analyses, and provides assistance with preclinical and clinical programs. Ms. Bailey has particular expertise in preparing sponsors for Medical Devices Advisory Committee panel meetings, and in supporting other premarket FDA interactions on behalf of a sponsor. Ms. Bailey has supported the development and commercialization of a wide variety of products including in vitro diagnostics, devices for the treatment of women’s health issues and diabetes management devices. Prior to NSF Health Sciences, Ms. Bailey was a Managing Director for Innovative Healthcare Products at Becker & Associates Consulting.
Caroline Rhim, Ph.D. - Executive Director, Medical Device Consulting
Phone: + 1 202.828.1581
Caroline Rhim brings over 10 years of experience in the medical device and public health sectors to NSF International, where she focuses on providing strategic and hands-on consulting services for clients looking to develop and market innovative medical devices. Dr. Rhim is an expert in navigating the U.S. regulatory landscape, tackling challenging premarket submissions and developing efficient regulatory strategies. Prior to joining NSF International, she served as Chief of the Anterior Spine Devices Branch at the FDA’s Center for Devices and Radiological Health (CDRH). She was also a lead scientific reviewer for premarket submissions (premarket approval (PMA), 510(k) premarket notification, investigational device exemption (IDE) submissions, etc.) in both the Divisions of Orthopedic Devices and Cardiovascular Devices. During her career at the FDA, she was involved in streamlining premarket and postmarket review processes as well as the classification efforts for posterior cervical screw systems. Dr. Rhim received Bachelor and Master of Science degrees in materials science and engineering from MIT and a doctorate in biomedical engineering from Duke University.
Oliver Christ, Dipl.-Ing. - Executive Vice President, PROSYSTEM, an NSF International Company
Phone: +49 40-66 87 88-102
Oliver Christ has been active in international standardization efforts for more than 25 years and co-founded PROSYSTEM with the late Dr. Jürgen Stettin in 1999. The company was acquired by NSF International in 2017. In Germany, Mr. Christ has served as chair or co-chair of national committees including Human Factors/Usability for Medical Devices, Risk-Management for Medical Electrical Equipment, and Software for Medical Devices and Networked Medical Systems. Mr. Christ represents Germany on international standard committees for programmable electrical medical systems, human factors, risk management, software life cycle processes, and risk management for IT-networks incorporating medical devices (published as IEC 80001-1:2010). In 2013 Mr. Christ became an international delegate for Germany for the AAMI/UL initiative UL 2800 on Interoperability for Medical Devices. He received the DKE Needle award in 2014.
Randolph Stender, Dipl.-Ing. - General Manager, PROSYSTEM, an NSF International Company
Phone: +49 40-66 87 88-103
Randolph Stender has over 20 years of experience in the medical device industry, including 16 years as a managing consultant and lead auditor for international medical device companies. Mr. Stender supports clients worldwide with the optimum management of complex projects and interim management. Mr. Stender has a university degree in biomedical engineering and is an active member of ISO TC 210/WG1 on ISO 13485, TC210/JWG1 on ISO 14971, and a number of other national committees and associations.
Robert Ruff - Robert Ruff, Executive Director, Medical Device Certification and Training
Phone: + 1 202.822.1850
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.
Robyn Meurant - Executive Director, Regulatory Team, IVDs and Medical Devices
Phone: +33 6 76 62 76 51
Robyn Meurant has more than 30 years of experience in the field of IVDs, as a laboratory scientist and as a regulator with the Australian Therapeutic Goods Administration (TGA) and with World Health Organization (WHO) Prequalification. Ms. Meurant began her career working in several large diagnostic laboratories in the role of senior scientist. In her position at TGA, Ms. Meurant assisted in developing the new regulatory framework for IVDs. With WHO, she served as the lead technical officer for application evaluation and dossier assessment, and as lead for the development of guidance and technical specifications for IVDs in the scope of WHO Prequalification. In addition, she has contributed to standards development and has been a source of expert advice to the Australian government on IVDs. In 2009 she was awarded the Distinguished Service Award by the Australian Society for Microbiology.