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RISA Case Study of Physician Interaction in the Medical Device Development Process
Publisher: The American Society of Mechanical Engineers (ASME)
Abstract: A multiphase empirical field study is being conducted at Stanford University to examine the process of physician interaction during medical device development. The initial component of this study ...
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 ...