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RISPolicy-Induced Constraints in the Design and Commercialization of Monitoring Devices: An Assessment of Three Technologies’ Reimbursement Models
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: Successful commercialization of medical technologies increasingly requires developers and manufacturers to think early-on about regulatory approval and reimbursement strategies for their new devices. ...
Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: Medical device regulation plays a significant role in promoting and protecting the public health. But the regulatory process and its requirements also exercise substantial influence over the ...
Review of U.S. Medical Device Regulation
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: Medical device regulation plays a significant role in the design, development, and commercialization of new medical technologies. A comprehensive understanding of the various regulatory requirements ...
Stage-Gate Process for the Development of Medical Devices
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: The medical device development process has become increasingly complex in recent years. The advent of new technology concepts, stricter regulatory requirements, and the ever increasing importance ...