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3rd party servicing is expected to see a big uptick in legislative activity in 2022. FDA maintains that there is no evidence of a risk to public health. However, a significant number of 3rd party servicers are engaging in re-manufacturing of medical devices which does pose a risk to public health. The lack of oversight is allowing this type of activity to go unchecked and is significantly under reported.
This session will explain the difference between servicing and re-manufacturing a medical device, outline the differences in regulatory requirements for 3rd party servicers vs re-manufacturers vs original equipment manufacturers (OEMs), present case studies of issues and concerns with unregulated 3rd party servicing activities as well as discuss potential solutions to this growing problem.
Audience Learning Level:
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
After this program, participants will:
Who Should Attend?
Jeff Ballyns, PhD is an associate director of regulatory policy at Becton Dickinson and Company (BD). He is responsible for gathering, assessing and communicating new regulatory policy requirements impacting BD businesses. Prior to working at BD, Ballyns worked in the Center for Devices and Radiologic Health (CDRH) at the US Food and Drug Administration (FDA) for eight years. While at FDA, he served as a lead reviewer, branch chief and division director in the Division of Radiological Health within the Office of In Vitro Diagnostics and Radiological Health. He was responsible for the premarket review and postmarket regulation of radiological imaging devices and artificial intelligence (AI) image analysis software applications. Ballyns earned his PhD in biomedical engineering from Cornell University.
Peter Weems is senior director of policy and strategy at the Medical Imaging & Technology Alliance (MITA), the primary trade association and standards development organization representing the manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media and focused ultrasound devices. In this role, he is responsible for policy development on a range of issues, including medical device servicing and patient safety. Weems has led publication of multiple technical publications on the issue, including a quality management system standard, NEMA/MITA 2 – Requirements for Servicing Medical Imaging Devices. Prior to joining MITA, he worked as an associate at van der Walde & Co and served two years as a Peace Corps volunteer in the Republic of Armenia.
G. Wayne Moore is CEO of Acertara Acoustic Laboratories. He is a 40-year veteran of the diagnostic ultrasound market and has held senior-level positions with major medical equipment manufacturers, including Honeywell Medical Systems and Siemens Medical Solutions. He has been directly involved in the development and commercialization of more than 20 technologically intensive ultrasound systems. He is widely published in the diagnostic ultrasound literature, a sought-after speaker at medical imaging and technical conferences, has served as an expert witness in multiple ultrasound litigations, and is a co-author on more than 25 US and international ultrasound-related patents. Moore is the 2022 ultrasound chair for the MITA Ultrasound Section, 2022 chair for the MITA Service Committee and is co-chair on the Output Standards Committee of the American Institute of Ultrasound in Medicine (AIUM). He was elected as a Fellow of the American Society of Echocardiography (FASE) in 2009 and a Fellow of the American Institute of Ultrasound in Medicine (FAIUM) in 2020. He earned his MBA from the University of Denver, Daniels College of Business.
Robert Z. Phillips is head of quality, regulatory and EHS – North America at Siemens Health. He is responsible for regional quality operations, systems and regulatory compliance across North America for the entire Siemens Healthineers’ healthcare product portfolio of medical imaging, radiation therapy planning and treatment, and in vitro diagnostic devices. Prior to his current role, Phillips served as the vice president, quality operations, systems and regulatory compliance for the global laboratory diagnostics business area with Siemens Healthineers. He led quality operations and cross‐functional processes across 10 domestic and international manufacturing sites; established future‐state regulatory intelligence and compliance strategies to predict and respond to emerging global requirements; and participated in the clearing of FDA Warning Letters. Prior to Siemens, he led quality and regulatory affairs teams at Boston Scientific, Philips Healthcare and Teleflex. Phillips is the industry representative to FDA’s Advisory Committee on Device Good Manufacturing Practices, which is currently supporting FDA’s potential transition from the QSR to ISO 13485.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
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RAPS will send an electronic letter or a certificate of attendance following the workshop.