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.
Elaine Messa, RAC, FRAPS - President, Health Sciences Medical Devices
Elaine Messa has over 30 years of experience in FDA regulation of medical devices, focused on the development and implementation of compliant quality systems for medical devices in the United States and abroad. Her most recent position at FDA was Director of the Los Angeles District. Ms. Messa has significant experience in auditing, agency communication, development of quality systems, and design and implementation of corrective action plans to address complex compliance situations including consent decrees, Corporate Integrity Agreements, warning letters and 483s.
Mary C. Getz, Ph.D. - Vice President, Quality Systems & Compliance
Mary Getz has over 25 years of industry experience, including extensive expertise in developing quality, compliance and regulatory affairs strategies and solutions. She has helped domestic and international manufacturers to develop and implement comprehensive compliance action plans. The results were effective quality systems which lead to successful FDA and notified body inspections as well as NDA and PMA product approvals. Dr. Getz has hands-on experience with IVDs, 510(k) and PMA medical devices, as well as OTC and NDA pharmaceuticals. She has held vice president-level roles in quality and regulatory affairs at numerous multinational companies in the healthcare sector.
Kristen Grumet - Executive Director, Quality Systems
Kristen Grumet has over 25 years of experience including nine years at FDA as a Field Investigator specializing in the area of medical devices, and 16 years working and consulting for medical device companies in quality systems compliance. At FDA, Ms. Grumet served on the Design Control Inspection Strategy (DCIS) and Pacific Region Design Control Training Cadre teams to develop, implement and train industry on the use of the DCIS questionnaire in FDA medical device inspections. She was a Phase II certified performance auditor and a member of the first FDA cadre of certified medical device investigators. She conducted numerous medical device inspections in Europe with the FDA foreign inspection cadre, and has managed successful third-party certifications for companies under FDA consent decree. She holds a BA in environmental population and organismal biology from the University of Colorado.
Meaghan Bailey, RAC - Senior Director
Meaghan Bailey’s expertise is in the analysis of complex regulatory challenges, and her work 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.
James Pink – Vice President, Europe, NSF Health Sciences Medical Devices
James Pink has 16 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. His industry experience includes managing development and quality assurance programs for orthopedic, cardiovascular, wound and combination products. Mr. Pink has a team of experts based in Europe who have over 20 years’ individual experience in both competent authority and notified body leadership. He has coordinated and presented to EU competent authorities and expert working groups relating to classification decisions, clinical study design, scientific and technical briefings, and EU remediation strategies.
Yvonne Middlefell - Executive Director, Regulatory Affairs
Yvonne Middlefell leads our European regulatory strategy and clinical services and has extensive experience in global medical device regulatory affairs. She has worked for key multinational corporations including Amersham Nycomed, Eastman Kodak and Bausch & Lomb and had a 25-year tenure at Johnson & Johnson. Her RA experience includes developing global regulatory strategies for IVDs, medical devices, OTC products, biologics and pharmaceuticals. Ms. Middlefell has written and filed multiple CE technical files and US 510(k)s for products that include immunoassays, clinical chemistry analyzers, infectious disease products, contact lenses and solutions. In addition, she has successfully managed a full PMA for an IVD US product submission. She was her company’s primary interface with regulatory agencies and industry bodies such as AdvaMed (USA) and EDMA (EU).
John Lang, Ph.D., DABT − Executive Director, Regulatory Science and Product Safety
John Lang is a medical devices and pharmaceutical safety expert with over 30 years' experience in the assessment of complex medicines/medical devices. He leads NSF’s European regulatory science and product safety services, providing biological safety assessments, developing product safety test methods, and helping clients interpret global regulatory requirements and plan pre-clinical, clinical and post-market studies. Dr. Lang is a board certified toxicologist, has worked with Upjohn Ltd and Smith and Nephew in product safety assurance, and founded Medwise International Consultancy. He chairs BSI Committee CH/194 on biological evaluation of medical devices, convenes ISO/TC 194 WG14 Material Characterization, is a member of ISO/TC 229 Nanotechnologies WG3, Environment, Health & Safety, and is a liaison from ISO/TC 194 to ISO/TC 229.
Greg Openshaw – Head of Training & Education
Greg Openshaw has 16 years’ operations and project management experience in the financial and health science industries. He is primarily responsible for the initiation of consulting, training and auditing programs, ensuring financial, operational and logistical activities are planned in line with our clients’ needs. His industry experience includes the development of global company learning and competency academies facilitating the development of specific training, education and qualification programs for various disciplines across highly regulated areas. Holding qualifications in senior management and human resource development, Mr. Openshaw is highly involved in the management of our Qualified Person program as well as our professional certification and post-graduate qualifications.
Alastair Selby - Biomedical and Regulatory Scientist
Alastair Selby has been working in the medical device industry as a regulatory science specialist for three years. Working prior to that in academia, he uses his background in biomedical materials science to add theoretical and technical expertise to the NSF Medical Devices team.
Mr. Selby is a Level 1 Medical Device Qualified Person. He has successfully written and contributed to multiple regulatory science documents and submissions, including clinical evaluations to EN ISO 14155 & SG5/N2R8, risk management files to EN ISO 14971, biological evaluations to EN ISO 10993, design history files, human factors and usability studies, and clinical investigation applications.
Ronald M. Johnson - Expert Consultant
Ron Johnson has more than 30 years of senior FDA leadership experience as well as 14 years of applied consulting practice assisting FDA-regulated companies with complex regulatory and compliance matters, particularly in the field of medical device compliance and quality systems. Through numerous senior FDA management positions at the district office level and at the Center for Devices and Radiological Health (CDRH), and experience as a trusted advisor to industry, both as a consultant and a valued board member for pharmaceutical corporations, Mr. Johnson has developed a uniquely multi-faceted perspective on regulatory and compliance issues.
Mr. Johnson’s wide ranging experience and resulting intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry enable him to develop and execute strategic, timely solutions for industry that both meet current client needs and anticipate potential future issues.
Timothy Ulatowski - Expert Consultant
Timothy Ulatowski has over 36 years of public health experience, including more than 20 years in multiple leadership positions at FDA’s Center for Devices and Radiological Health (CDRH). He most recently served as Director of the Office of Compliance at CDRH, where he managed and supervised four divisions responsible for ensuring compliance with medical device regulations. Mr. Ulatowski has proven expertise in advising industry on regulatory issues, assessing compliance and enforcement actions, evaluating premarket documents, and resolving complex technical and scientific problems.
Harold “Wally” Pellerite - Expert Consultant
Wally Pellerite is the former Director of Strategic Compliance at Quintiles Consulting in Maryland, where he applied his significant experience with regulatory requirements for medical devices and experience in evaluating and resolving compliance and enforcement issues. From his 30 year career within FDA’s Center for Devices and Radiological Health (CDRH), Mr. Pellerite has an extensive historical knowledge of FDA enforcement strategies, policies, and actions. He works with clients to develop and execute cost-effective gap analyses and corrective action plans in response to FDA 483s, Warning Letters, and other regulatory actions. He is recognized as an expert in the Medical Device area and has served as an expert witness in numerous civil cases.
As an expert consultant, Mr. Pellerite helps guide the development of NSF’s medical device compliance practice in addition to providing technical consulting solutions for clients.
Steve Yost - Principal Consultant
Steve Yost has over 13 years of experience in FDA regulated industry, primarily in medical device manufacturing. He has served as an FDA Consumer Safety Officer in the Office of Regulatory Affairs, receiving numerous awards for outstanding performance, including a nomination for the Patrick J. Poulzer National Investigator of the Year Award. His efforts since leaving FDA have focused on the development and implementation of quality systems for the medical device industry in the US and abroad, as well as the creation and submission of 510(k)s and PMAs. He has also held various management positions in quality and regulatory departments at medical device, IVD, and human cellular and tissue product manufacturers. Steve’s areas of expertise include auditing, audit preparation such as mock FDA audits, quality system remediation, regulatory submissions and the development of responses to warning letters and FDA 483s. Mr. Yost has a bachelor’s degree in molecular biology from the University of Colorado.
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- 7 months ago
ANN ARBOR, Mich. USA — NSF International, a global public health organization, has acquired the auditing subsidiary of the International...
- 7 months ago
ANN ARBOR, Mich. - Global public health organization NSF International has integrated subsidiary companies NSF Becker & Associates, NSF-DBA and...
- Monday, September 22, 2014
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- Manchester, United Kingdom
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- Monday, September 29, 2014
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