Medical Device Experts
With an integrated approach and in-house medical device regulatory and clinical trial professionals, Aptiv Solutions is perfectly positioned to help clients respond to the increased rigor demanded by worldwide regulatory agencies for medical device development, approvals and ongoing compliance.
Click on each name for more information.
Vicki Anastasi | Senior Vice President
Ms. Anastasi provides business development leadership to create and foster priority relationships in the medical device and diagnostic marketplace, developing customized programs to meet medical device client needs. She has over twenty years of experience in the medical device industry, with over fifteen years specifically focused on device regulation.
Prior to joining the company in 2007, she served as director of regulatory affairs at TissueLink, Inc., (Salient Surgical / Medtronic Advanced Energy) 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, supporting the company’s 3-D visualization and surgical solutions for minimally invasive cardiothoracic, head, neck and spine, and other microsurgical procedures. In diagnostics, she held senior positions at ATC Diagnostics, Inc. and bioMerieux Vitek, Inc., where she managed regulatory activities related for infectious disease and genetic-based products.
Bernard Sweeney | Senior Vice President
Mr. Sweeney collaborates with EU medical device and IVD clients to deliver product development, global regulatory affairs, and clinical trial management solutions. He brings more than 20 years of experience that includes operational, strategic, regulatory and clinical trial expertise.
Prior to joining Aptiv Solutions he served as Vice President at D Target, the medical device division of Premier Research, reporting to the board, where he headed up all device activities operational and commercial within the division. Before that, he was Director of Healthcare at the British Standards Institute (BSI), a full-service Notified Body, where he led healthcare certification operations and oversaw a team of 80 technical specialists providing assessments, certifications and standards services to medical device and IVD companies. In industry, Mr. Sweeney worked as Managing Director for Femcare-Nikomed Ltd, a global organization of medical device companies with a portfolio of products in gynecology, general surgery and urology. He also held Director and senior management positions at Huntleigh Healthcare and Beiersdorf.
Michael L. Felstein, PhD | Senior Vice President
Michael brings over 40 years of experience in the design and analysis of clinical trials. He provides high-level strategic guidance to emerging and established medical device clients in the areas of study design and biostatistics.
From 1997 to 2011, Michael oversaw clinical operations and biostatistics services at Medical Device Consultants, Inc., a full service medical device CRO, which became part of Aptiv Solutions in 2011. Prior to joining industry he was a professor of Biostatistics at Harvard University School of Public Health, where he directed the department’s Consulting Laboratory. He has authored or co-authored over eighty publications in medical journals and has given numerous presentations to professional societies. He is a member of the American Statistical Association and holds a Ph.D. in statistics from the State University of New York at Buffalo.
Erdmann Zippel | Senior Director, Clinical Operations
Mr. Zippel brings more than 13 years of experience within the medical device, CRO, and biotech industries, and has specific expertise managing medical device clinical studies throughout Europe in the fields of cardiology, angiology, anesthesia/intensive care, orthopedics and neurology. He most recently served as Executive Director, Europe at D-TARGET, responsible for project management and resourcing of all EU projects, and overseeing a team of project directors, clinical research managers, clinical research associates, regulatory affairs managers, and quality assurance managers. His industry experience includes senior clinical research positions at Laryngeal Mask Company Ltd., now a Teleflex company, where he supported the development of anesthesia, urology and orthopedic devices. At Biotronik, a market leader in the CRM business, he was involved in clinical research, training, regulatory and technical support activities for pacemaker, ICD, heart failure and telemedicine devices. Prior to joining industry in 2001, he spent 12 years as a registered nurse focused on hospital intensive care and anesthesia.
Susan M. Rockwell | M. Ed., Executive Director
Susan works with medical device clients to assess their needs and requirements for cost-effective and timely solutions. She has over twenty-five years of experience in clinical and healthcare research. For the past twenty years, she has worked in the CRO industry with clinical operations and more recently with business development. She has particular expertise in the management and oversight of clinical trials for cardiovascular, orthopedic, and urological devices, as well as in vitro diagnostics.
Prior to joining MDCI (now Aptiv Solutions) 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 has served on the Board of Trustees, Chair of the 2011 Global Conference, Chair of the Editorial Advisory Board, Chair of the Device Forum and is currently Chair of the Nominating Committee. She holds a M.Ed. in Health Education from Boston University and a B.A. in Biology from the University of Virginia.
Cynthia J. Nolte | PhD, Director, Regulatory Services
Dr. Nolte has over 15 years of experience in medical device regulatory affairs and has contributed to the successful launch of over 100 medical devices. She works closely with clients to develop and implement regulatory strategies, communicate with FDA and international regulatory agencies, and submit regulatory documentation. Her expertise includes complex medical device products and systems including drug delivery systems, stand-alone software products, software-controlled instrumentation, implantable devices, infection control products and tissue engineered products. She is also an expert in the design and execution of human factors testing for medical devices.
Cynthia Sinclair | Director, Regulatory Services
Ms. Sinclair has over 30 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 (IVD) products, including the development of regulatory strategies, design of analytical and clinical study protocols, and the preparation of regulatory submissions.
Prior to joining Aptiv Solutions, she was director of Quality Assurance and Regulatory Affairs at Ortho Diagnostic Systems, Inc., a Johnson & Johnson Company, where she directed all regulatory affairs and compliance functions from product design and development through product introduction for IVD reagent and instrument systems. Cynthia is Regulatory Affairs Certified and a member of the Regulatory Affairs Professionals Society, the American Association for Clinical Chemistry, and the Clinical and Laboratory Standards Institute.
Frederick Tobia | Director Regulatory Services
Mr. Tobia brings over 20 years of experience in the medical device and CRO industry and has held senior executive roles in regulatory, quality and clinical affairs at Alliant Medical Technologies, Inc. (formerly UroMed), CareStat Inc., and Seacoast Technologies. Before joining Aptiv Solutions, he was Vice President, Regulatory and Clinical Affairs at NMT Medical Inc. He has successfully gained clearance and approval of PMAs, 510(k)s, IDEs, INDs, NDAs, BLAs, and international design dossiers with and without clinical data. Fred holds a B.S. in biology from Providence College and a Certificate in Public Health from Harvard School of Public Health. He has published numerous articles in peer-reviewed journals and is a recognized speaker and advisor to medical device industry trade and professional organizations, including FDA task forces.
Ron Warren | Director Regulatory Services
Mr. Warren has over 25 years of regulatory, quality and clinical affairs experience, with expertise in a wide range of medical device products, including in human-derived tissue engineered products, in vitro diagnostics, combination products, cardiovascular devices, and electronic medical systems. He has led multiple pre-IDE meetings and overseen the submission and preparation of PMAs, 510(k)s, PMA Supplements, and IDEs for various clinical indications.
Prior to joining Aptiv Solutions, Ron held senior and executive level regulatory and quality assurance positions at Smith & Nephew Wound Management, Advanced Tissue Sciences, Inc., Sorin Biomedical, and Baxter Healthcare. He is Regulatory Affairs Certified.