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 compliance 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
Dr. 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.
James Pink – Vice President, Europe, NSF Health Sciences Medical Devices
Mr. 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 as well as EU remediation strategies.
Meaghan Bailey, RAC - Senior Director, Regulatory and Clinical Services
Meaghan Bailey is Senior Director at NSF Health Sciences Medical Devices. Ms. Bailey’s activities include analysis of complex regulatory challenges, development of regulatory strategies for innovative products, preparation of regulatory submissions, literature review and analysis, and assistance with preclinical and clinical programs. Ms. Bailey has particular expertise in preparing sponsors for FDA Medical Device Advisory Committee panel meetings. She 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 mobile medical applications. She also has extensive experience in the area of diabetes management devices. She was previously the Healthcare Investor Events Manager at Guidepoint Global in New York City, an independent primary research firm to institutional investment funds. Ms. Bailey holds a Bachelor of Arts with highest distinction in human biology, an interdisciplinary distinguished majors program, from the University of Virginia. She graduated Phi Beta Kappa.
Deborah Baker-Janis - Director, Regulatory and Clinical Services
Deborah Baker-Janis has over 10 years of experience in the medical device industry, including positions in both regulatory affairs and product development. Her experience includes the development of pre-clinical testing protocols, FMEA documentation, quality system and regulatory affairs standard operating procedures, sales training materials, MDR and safety reports, and domestic and international regulatory strategies and submissions. Ms. Baker-Janis has supported the development and commercialization of a wide range of products including animal tissue-based wound dressings and surgical meshes and interventional radiology devices including stents, catheters and guidewires. Her educational background is in biomedical engineering, which has proven to be an asset in understanding the technical challenges companies face in bringing products to market and in recommending solutions based on engineering principles.
Yvonne Middlefell, RAC, FRAPS - Executive Director, Regulatory Strategy and Clinical Services
Ms. Middlefell leads our European regulatory strategy and clinical services and has extensive experience in global medical device regulatory affairs. She has worked for a number of key multinational corporations including Amersham Nycomed, Eastman Kodak, Bausch & Lomb and 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 a range of 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 U.S. product submission. She was her company’s primary interface with regulatory agencies and industry bodies such as AdvaMed (USA) and EDMA (EU).
Katherine C. Norris, MPA - Senior Director, Compliance & Integrity Programs
Ms. Norris has over 10 years of experience in corporate governance and compliance in the pharmaceutical, medical device, OTC consumer products and cosmetics industries. She has performed substantial internal investigations and supported extensive federal investigations with multiple agencies, including the United States Department of Justice, Health and Human Services Office of Inspector General and the Securities and Exchange Commission. Ms. Norris assists clients with internal and external investigations, remediation of cross functional compliance concerns (including implementation and compliance with CIAs and DPAs), and the operational aspects of compliance program development, management and oversight, including aggregate spend initiatives.
Michelle Garrett - Operations Manager, U.S.
Ms. Garrett is a results-oriented project manager with a proven track record of effectively managing small- to large-scale quality, compliance and process optimization projects. She has demonstrated success with both medical device and pharmaceutical clients, and ensures that project deliverables are provided with a high degree of professionalism and within identified timeframes that meet or exceed quality and budgetary expectations. Ms. Garrett works effectively with clients to ensure adoption of FDA and ISO requirements, as well as developing optimized business process strategies to improve operational efficiencies. She has worked with multiple clients in the medical device and pharmaceutical industries to ensure compliance with regulatory agencies, as well as increased efficiencies and a significant return on investment. Ms. Garrett also possesses ten years FDA experience working as a member of the Drug and Medical Device Teams within the Los Angeles and Chicago Districts, as well as significant expertise in coordinating compliance strategies and corrective action plans to mitigate risk. She manages project team activities to ensure deliverables meet client’s requirements, and interfaces with clients and internal personnel to oversee project activities as well as implementing program management policies and procedures.
Greg Openshaw - Operations Manager, UK
Mr. Openshaw has 16 years operations and project management experience in both the financial and health science industries. He is primarily responsible for the initiation of our various consulting, training and auditing programs, ensuring financial, operational and logistical activities are planned in line with our client’s 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 such as insurance, financial services and NSF’s medical device Qualified Person program.
Holding qualifications in senior management and human resource development, Mr. Openshaw is responsible not only for the operations management of our European consulting projects, but is also highly involved in the management of our Qualified Person program representing NSF Health Sciences academic qualifications and managing our team of instructors for both our public and in-company training as well as our professional certification and post-graduate qualifications.
Ben Shand, MBE - Practice Manager
Ben Shand is a Practice Manager at NSF Health Sciences Medical Devices. Mr. Shand’s activities include development of project proposals and budgets, coordination and resourcing of cGMP audits and consent decree remediation projects, composition of audit plans and reports, and preparation of QSR and FDA inspection readiness training materials. Other activities include assisting with client responses to FDA enforcement actions, such as warning letters and Form FDA 483s, and assuring the quality of final work products.
Mr. Shand previously worked as a Program Management Analyst for Science Applications International Corporation (SAIC) in Frederick, Maryland. He has interned for Team Consulting in Cambridge, United Kingdom and worked in a proteomics laboratory under NIH and a cardiovascular disease research laboratory at the University of South Carolina, School of Medicine.
Mr. Shand holds a B.S. in biology from the University of South Carolina and a master’s degree in bioscience enterprise from the University of Cambridge.
Ben Berg - Practice Manager
Ben Berg is a Practice Manager at NSF Health Sciences Medical Devices. Mr. Berg’s activities include development of project proposals and budgets, coordination and resourcing of cGMP audits and consent decree remediation projects, composition of audit plans and reports, and preparation of QSR and FDA inspection readiness training materials. Other activities include assisting with client responses to FDA enforcement actions, such as warning letters and Form FDA 483s, and assuring the quality of final work products.
Mr. Berg previously worked as a Research Assistant at the Department of Neuroscience at the University of Pennsylvania conducting research that focused on the mechanism and therapeutic treatments for the developmental disorder polyhydramnios megalencephaly and symptomatic epilepsy.
Mr. Berg holds a B.A. in the biological basis of behavior from the University of Pennsylvania.
Rami Amir - Research Associate
Rami Amir is a Research Associate at NSF Health Sciences. He provides research support to clients, including conducting literature searches, preparing reports and regulatory submissions, and developing databases for client projects. Rami previously interned at a private healthcare organization in southern New Jersey where he assisted directors in finance, legal and project development departments and conducted various research projects. He also has working experience as a pharmacy technician at AtlantiCare Regional Medical Center in Atlantic City, New Jersey.
Mr. Amir holds a B.A. in philosophy, politics and economics from the University of Pennsylvania where he graduated with honors.
Ron Johnson - Consultant
Mr. Johnson has more than 30 years of senior FDA leadership experience as well as 14 years of applied consulting practice experience 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 prominent FDA leadership positions include CDRH Director of Compliance and CDRH Director of the Pacific Region. In the latter position, he managed the execution of FDA’s consumer and enforcement programs in the nine western states (including Hawaii and Alaska) and the Pacific Trust Territories, including the activities of 600 administrative, inspectional, laboratory and compliance personnel stationed in three of FDA’s largest field installations. Mr. Johnson has also played an active role in the development of FDA policies and training of personnel as Chair of FDA’s Public Affairs Field Committee, Chair of FDA’s Human Resources Field Committee, a member of FDA’s Enforcement Policy Council, and Course Leader for FDA’s Evidence Development Training Program for New Investigators and Analysts.
He has received numerous awards in recognition of his government service and leadership, including multiple FDA Commissioner Special Citations, three FDA Awards of Merit, ten “Hammer” Awards from Vice President Al Gore and the National Performance Review, a U.S. Public Health Service Superior Service Award and a citation for exemplary leadership in FDA by the U.S. House of Representatives Oversight Committee.
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.
Wally Pellerite - Consultant
Mr. 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 with FDA’s Center for Devices and Radiological Health (CDRH), Mr. Pellerite has an extensive 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.
During his three decades of CDRH service, Mr. Pellerite spent 20 years as the Assistant to the Director, Office of Compliance (OC). He also served as a Senior Advisor to the Office and to Center Directors and was the initial contact for compliance and enforcement issues for FDA field offices, legal counsel, corporate executives and international executives from the private and government sector. His main areas of expertise include medical device reporting (per 21 CFR Part 803), complaint handling, and corrective and preventive actions (CAPAs). Mr. Pellerite also trained FDA staff on labeling requirements (per 21 CFR Part 801) and evaluating off-label use.
Larry Schum - Consultant
Larry Schum is a compliance expert consultant at NSF Health Sciences Medical Devices. Mr. Schum has over 30 years of domestic and international experience in the medical device industry, as well as experience in the pharmaceutical industry.
Mr. Schum specializes in the quality systems requirements of the Food and Drug Administration (FDA), and he consults with the medical device industry on quality system development, compliance auditing and developing and implementing corrective action plans. He has assisted medical device companies under consent decrees by implementing appropriate corrective actions and assisting the firms in passing external certification audits. In additional to his corrective and preventive action systems expertise, Mr. Schum also has developed design control systems, management controls systems and production and process control systems. He regularly performs audits, gap analyses and responses to 483s and warning letters.
Mr. Schum earned a Bachelor of Science in industrial management from Purdue University and an MBA in quantitative methods from St. Francis College. He also served as an adjunct faculty member for the University of Kansas Graduate School of Engineering. He has been a speaker for the Food and Drug Law Institute and is a member of the Regulatory Affairs Professional Society.
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