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    Review of U.S. Medical Device Regulation 

    Source: Journal of Medical Devices:;2007:;volume( 001 ):;issue: 004:;page 283
    Author(s): Jan B. Pietzsch; Lauren M. Aquino; Paul G. Yock; M. Elisabeth Paté-Cornell; John H. Linehan
    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 ...
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    Stage-Gate Process for the Development of Medical Devices 

    Source: Journal of Medical Devices:;2009:;volume( 003 ):;issue: 002:;page 21004
    Author(s): Jan B. Pietzsch; Lauren A. Shluzas; M. Elisabeth Paté-Cornell; Paul G. Yock; John H. Linehan
    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 ...
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