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Our regulatory, clinical, and quality assurance and compliance staff have the experience and skills you demand. We will ensure that your project is handled with utmost priority and attention to detail. Because MDCI is a registered ISO 9001 service provider, you can be assured of our commitment to quality and client satisfaction.
EXECUTIVE MANAGEMENT
William A. Morton, RAC, President
William has over thirty years of experience in the field of medical device research, development, and regulatory compliance. Prior to founding MDCI in 1980, he was Director of Regulatory Affairs and Clinical Studies for AVCO Medical Products Division of AVCO Corporation. Bill has contributed numerous publications to scientific literature and is a member of the Regulatory Affairs Professionals Society (RAPS), the American Society of Artificial Internal Organs (ASAIO) and the Association for the Advancement of Medical Instrumentation (AAMI). He serves on the editorial advisory boards for Medical Product Outsourcing and Medical Device Technology. He is a member of the Board of Directors for RAPS and served as Chairman of the Regulatory Affairs Certification Board for RAPS from 2003 to 2006. He holds a B.S. in Materials Science from San Jose State University and is Regulatory Affairs Certified.
Michael L. Feldstein, Ph.D., Vice President, Clinical Services
Michael oversees all activities of MDCI’s clinical services group, consisting of project managers, data managers, SAS programmers, clinical trial managers, and biostatisticians.
He has over thirty-five years of experience in the design and analysis of clinical trials. He is a former professor of biostatistics at Harvard University School of Public Health, where he directed the department’s consulting laboratory. He is a member of the American Statistical Association and the Biometric Society and holds a Ph.D. in statistics from the State University of New York at Buffalo.
REGULATORY SERVICES
Our regulatory consultants and advisors are former FDA officials, industry scientists, or have an industry regulatory affairs background.
Because of the depth of their background and experience, they can provide expert advice or assistance for virtually any type of medical device, in vitro diagnostic product, or combination product. They are particularly adept at formulating creative strategies and investigational plans for rapid approval of unique new products or new technologies.
Vicki Anastasi, Director, Regulatory Services
Vicki oversees all activities of the regulatory services group, which provides strategic consulting and submission preparation and review to U.S. and international clients. She has over eighteen years of experience in the medical device industry, with over fifteen years specifically focused on device regulation.
Prior to joining MDCI in 2007, Vicki served as director of regulatory affairs at TissueLink, Inc., where she was responsible for developing and implementing a U.S. and EU regulatory strategy for medical devices in the electro-surgery market. At Vista Medical Technologies, Inc. an emerging device manufacturer, she served as Regulatory Affairs Manager, responsible for regulatory activities supporting the company’s 3-D visualization and information systems to enable minimally invasive surgical solutions in cardiothoracic, head, neck and spine, general surgical and other microsurgical procedures. She is also experienced with in vitro diagnostic products, having held senior positions at ATC Diagnostics, Inc. and bioMerieux Vitek, Inc, where she was responsible for regulatory activities related to infectious disease and genetic-based products.
Vicki holds a B.S. in Medical Technology from the University of Connecticut. She is an active member of AdvaMed and participates in many of the organization’s industry working groups.
James (Randy) R. Veale, Senior Regulatory Advisor
Randy has over thirty years of experience in the regulation of medical devices by the Food and Drug Administration. Until 2005, Randy oversaw all activities of MDCI’s regulatory services group. Now, as a senior advisor, he is particularly skilled at working with clients to develop competitive regulatory strategies for novel and innovative medical devices.
From 1973 to 1984, he served at the FDA, where he was involved in the implementation of the 1976 Medical Device Amendments and the creation of the agency’s policies and regulations for medical devices. As a division director at CDRH, he was responsible for the scientific review and approval of hundreds of anesthesiology, neurology, and radiology medical device applications. Randy holds an M.S. in Electrical Engineering from the University of Wyoming.
Rosina Robinson, R.N., M.Ed., RAC, Principal Consultant
Rosina has over thirty years of experience in regulatory affairs and healthcare delivery. She has authored over 50 successful 510(k)s and many PMAs and PMA supplements for products representing a variety of medical specialties, with particular expertise in the regulation of cardiovascular, minimally invasive and general surgical devices. She guides clients through all types of premarket regulatory and clinical trial activities, and is especially skilled at facilitating face-to-face communications between clients and the appropriate FDA Center, including CDRH and CBER.
Prior to joining MDCI in 1992, she was manager of clinical research and regulatory approvals at Haemonetics Corporation. Rosina is a member of the Regulatory Affairs Professional Society, the Association of Operating Room Nurses, and the American Association of Blood Banks. She is a registered nurse, holds an M.Ed. from Bridgewater State College, and is Regulatory Affairs Certified. Rosina is also an adjunct professor in the Northeastern University Master of Science in Regulatory Affairs program.
Cynthia A. Sinclair, RAC, Principal Consultant
Cynthia has over thirty years of experience in the medical device field encompassing research and development, regulatory affairs, and quality assurance. She specializes in the regulation of in vitro diagnostic products, including the development of regulatory strategies, design of analytical and clinical study protocols, and the preparation of regulatory submissions.
Prior to joining MDCI in 1988, she was director of quality assurance and regulatory affairs at Ortho Diagnostic Systems, Inc., a Johnson & Johnson company. She directed all regulatory affairs and compliance functions from product design and development through product introduction for in vitro diagnostic reagent and instrument systems. Cynthia is a member of the Regulatory Affairs Professionals Society, the American Association for Clinical Chemistry, and the Clinical Laboratory Standards Institute. She holds a B.A. in chemistry from Northeastern University and is Regulatory Affairs Certified.
Ronald S. Warren, RAC, CTBS (AATB), Principal Consultant
Ron has over twenty-two years of regulatory and clinical affairs experience, with specific expertise in human-derived tissue engineered products and cardiovascular devices. He has coordinated and led multiple pre-IDE meetings and been involved in the submission and preparation of PMAs, 510(k)s, PMA Supplements, and IDEs for various clinical indications. He also has expertise in tissue establishment registration and Good Tissue Practice regulations.
Prior to joining MDCI in 2006, he served as executive director, regulatory affairs and quality assurance for Smith & Nephew Wound Management, and as head of regulatory affairs at Advanced Tissue Sciences, Inc. Prior to that, he was with Sorin Biomedical, Inc., where he managed regulatory and clinical activities for the company’s complete line of cardiovascular and cardiopulmonary products including heart valves, catheters, oxygenators, and blood cardioplegia delivery systems. At Baxter Healthcare Corporation, Edwards Cardiovascular Surgery Division, Ron was responsible for clinical and regulatory activities supporting the company’s prosthetic heart valves and biological vascular grafts. He holds a B.S. in biology from the University of California, Irvine and an M.B.A. from California State University, Long Beach. He is a certified Tissue Bank Specialist and is Regulatory Affairs Certified.
James Knox, RAC, Senior Regulatory Consultant
Jim has over twenty years of experience in regulatory affairs and healthcare delivery. He works with clients to develop and prepare premarket submissions to gain both FDA and EU marketing authorization for a variety of medical products.
Prior to joining MDCI in 2005, he was a consultant to the medical device industry providing assistance to medical device and pharmaceutical companies, with particular focus on the regulation and compliance of drug/device combination products. His experience includes the development of FDA and EU regulatory strategies and clinical studies for a variety of medical devices and biologics. Jim is a member of the Regulatory Affairs Professionals Society and the American Society of Management Consultants. He holds a B.S. in biochemistry from Rutgers University and an M.B.A. from Lake Forest Graduate School of Business Management. He is Regulatory Affairs Certified.
Mary McNamara-Cullinane, RAC, Senior Regulatory Consultant
Mary has over eighteen years of experience in regulatory and clinical affairs. She has varied expertise including the regulation of radiology, urology, physical medicine, orthopedic, wound care, and dental devices.
Prior to joining MDCI in 1992, she was the clinical affairs coordinator at Davol, Inc., subsidiary of C.R. Bard, where her responsibilities included preparation of FDA submissions and management of clinical trials. Mary also was a product development scientist at Hygeia Sciences, where her responsibilities included management of consumer studies and development of over-the-counter diagnostic products. Mary holds a B.S. in biology from North Adams State College and is a member of the Regulatory Affairs Professionals Society. She is Regulatory Affairs Certified.
Cynthia J. M. Nolte, Ph.D., RAC, Senior Regulatory Consultant
Cindy has over ten years of experience in medical device regulatory affairs, with varied expertise including the regulation of infection control products, software-controlled instrumentation, implantable devices, and tissue-engineered products.
Prior to joining MDCI in 1995, she was a staff scientist at Organogenesis, Inc., where she was involved in the design and development of cellular tissue substitutes. Cindy is a member of the Regulatory Affairs Professionals Society, the Association for the Advancement of Medical Instrumentation, and the North Carolina Regulatory Affairs Forum. She holds a B.A. in biology from Wheaton College and a Ph.D. in biochemistry from Boston University. She is Regulatory Affairs Certified.
Susan M. Bonapace, Regulatory Associate
Susan has over fifteen years of experience in the development and manufacture of in vitro diagnostic products. She works closely with manufacturers to achieve FDA marketing authorization for a variety of diagnostic products and systems.
Prior to joining MDCI in 2006, Susan held clinical research positions at Bayer Healthcare where she was responsible for project management and monitoring of in vitro diagnostic clinical studies. Her product experience includes the development of serology and nucleic acid assays, including diagnostic assays for Hepatitis C/B, HIV, and other infectious disease markers, for marketing in the U.S. and EU. Susan holds an M.S. in drug regulatory affairs from the Massachusetts College of Pharmacy and a B.S. in biological sciences from Glassboro State College.
CLINICAL SERVICES
The Clinical Services Department consists of a team of over twenty individuals who are expert in the design, implementation, and management of clinical studies. Senior staff both in the USA and Europe bring from six to thirty years experience in support of studies for regulatory submissions, marketing research, and publications.
Our senior-level project managers work collaboratively to plan, organize and coordinate pilot, pivotal, and postmarket clinical trial activities for a variety of medical device and in vitro diagnostic products. They manage and oversee day-to-day activities to ensure that sponsors and study teams are informed and on track to meet study objectives.
Our monitors are highly trained individuals with RN or health-related degrees, or past experience as clinical study coordinators at major teaching hospitals. All are involved in study coordination on a day-to-day basis and the reporting of clinical data to the client. We also have a network of highly selected contract monitors in Europe who, as native speakers, provide coverage for most of Western Europe.
MDCI has full service in-house data management and statistical services, including data entry operations, programmers, and biostatisticians.
Susan M. Rockwell, B.A., M. Ed., Manager, Clinical Trials and Clinical Development
Susan works with new and existing clients to assess their needs and develop cost-effective and timely solutions for the design, management, monitoring and data management of pilot, pivotal, and postmarket medical device and in vitro diagnostic product trials.
Susan has over twenty years of experience in clinical and healthcare research, with particular expertise in managing clinical trials for orthopedic, urological, and cardiovascular devices. Prior to joining MDCI in 1988, she coordinated cardiovascular drug trials at Boston University Medical Center and managed healthcare programs at the American Heart Association, Massachusetts Affiliate. Susan is an active member of the Association of Clinical Research Professionals, where she serves on the board of trustees and is chair of the editorial advisory board. She is also past chair of the ACRP device forum. She holds an M.Ed. in health education from Boston University and a B.A. in biology from the University of Virginia.
Jacqueline J. Barrows, RN, CCRA, HP (ASCP), Clinical Trials Manager
Jacqueline supervises, trains, and manages all in-house and contract clinical research associates (CRAs) to ensure that client studies are monitored and managed to meet both client expectations and relevant regulatory requirements.
Jacqueline has over nineteen years of experience in clinical training and clinical research for medical devices, specializing in blood cell separation technology and urology. At Haemonetics Corporation, she oversaw clinical product training and managed clinical research to support aphaeresis and auto transfusion products. At UroMed Corporation she managed clinical studies in the development of a nerve stimulator device and various urological surgical instruments. She is an ACRP certified clinical research associate and graduated from the Clinical Research Administration Certificate Program at George Washington University in Washington, DC.
Kristine Bello, MPH, Senior Clinical Project Manager
Kristine has specific experience with cardiovascular devices. Prior to joining MDCI in 2007, she held senior clinical research positions at NMT Medical, Inc. and C.R. Bard, Inc. She also served as clinical education project manager at Beth Israel Medical Center in Boston, MA. Kristine holds an M.P.H. from Boston University School of Public Health and a B.S. in veterinary science and technology from the University of Rhode Island.
Christine Delano, RN-MSN, ANP, Senior Clinical Project Manager
Chris has extensive experience with cardiovascular studies, specifically focused on stroke and congestive heart failure. Prior to joining MDCI in 2007, she was a clinical project manager for NMT Medical, Inc. and Cardiovascular Clinical Studies, Inc. She also held research positions at Tufts New England Medical Center and Fallon Healthcare System. Chris holds an M.S. in nursing from Massachusetts General Hospital and a M.S. in criminal justice from Northeastern University. She is a Nurse Practitioner and a member of the Association of Clinical Research Professionals.
Mindy D. Liss, M.Sc., Biostatistician
Ms. Liss has fifteen years of clinical trials experience with pharmaceuticals and medical devices. Prior to joining MDCI, she was the biostatistician at a Boston-area biotechnology company and at Parexel International Corporation. She has worked in the management and analysis of clinical trials in the areas of cardiovascular disease, autoimmune disorders and cancer. She holds a B.Sc. in Mathematics from McGill University and a M.Sc. from Harvard University School of Public Health in Biostatistics.
QUALITY ASSURANCE & COMPLIANCE SERVICES
We will work with you to find the most cost-effective method for achieving your quality goals and regulatory compliance. We will help you to design, assess, and implement the systems, procedures, and documentation to meet any of the regulations affecting your product; U.S. FDA Quality System regulation, ISO standards, European Medical Device Directives and Canadian Medical Device regulations.
Judith Andrews, Ph.D, RAC, CBA (ASQ), Director, Quality and Compliance Services
Judith has over twenty years of hands-on experience in the FDA regulation of medical devices. Judy has expertise with in vitro diagnostic devices and over-the-counter medical products and has held positions in product development, manufacturing, quality control and quality assurance at several companies including a fortune 500 company and several start-up firms.
Her demonstrated expertise in developing, implementing, and auditing quality systems, together with a “value-added” approach, is a strong fit for medical device manufacturers seeking to comply with QSR, ISO 13485:2003, MDD, IVDD, or Canadian Medical Device Regulation. She assists clients with recalls, U.S. and EU medical device reporting, and FDA 483s and warning letters.
Judy holds a Ph.D. in chemistry from Case Western Reserve University and an M.B.A. from Simmons Graduate School of Management. She is a certified biomedical auditor and is Regulatory Affairs Certified. She serves on the board of the New England chapter of the ASQ Biomedical Division and speaks regularly at industry and professional conferences, seminars and webinars.
MDCI maintains a network of affiliate quality and compliance consultants with experience in quality systems, quality engineering, and regulatory compliance. They assist clients in the areas of medical device audits, process validation, design control, quality system consulting, and training, as well as software quality assurance, product software validation, software regulatory compliance and validation of automated processes.
MEDICAL DEVICE CONSULTANTS INTERNATIONAL
John L. Webster, Managing Director, Europe
John manages all activities of MDCI’s UK office, which provides regulatory, clinical trial and quality assurance consulting support to EU and U.S. clients and serves as EU Authorized Representative for a large number of medical device manufacturers.
John has over twenty-five years of quality assurance, regulatory, and management experience. Prior to joining MDCI in 1997, he was director of regulatory affairs in Europe for Boston Scientific, Paris, France and director of regulatory affairs Europe, Middle East and Africa at Meadox Medical Inc.
John is a chartered chemist, member of the Royal Society of Chemistry (C. Chem, M.R.S.C.), a lead assessor, Lloyds Quality Management System Assessment and a certified quality engineer, American Society of Quality. He is a member of the Regulatory Affairs Professionals Society (RAPS) and serves on the RAPS European Regional Operating Committee (EUROC). He served as vice chairman technical for the European Confederation of Medical Device Manufacturers (EUCOMED) during the evolution of the Medical Device Directive. He is a graduate of the Royal Institute of Chemistry, Newcastle Upon Tyne University and has a diploma in management studies from the University of East Anglia.
Speak with a Consultant
Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or click here and a consultant will contact you directly.
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