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Journal Articles

Harnessing Experience for Efficient Medical Device Product Development

L. Lucke, D. Anderson, D. Smith
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Design Of Medical Devices Conference Abstracts
J. Med. Devices. June 2009, 3(2): 027551.
https://doi.org/10.1115/1.3147388
Published Online: July 24, 2009
... and power systems are necessary for rapid development. Processes including project planning and tracking, requirements management, configuration management, risk analysis, and manufacturing design transfer are essential for streamlining development as well as ensuring support for regulatory submissions...
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Topics: Medical devices, Product development, Risk analysis, Safety, Design, Manufacturing, Risk, Teams, Biomedical equipment, Blood
Journal Articles

Review of U.S. Medical Device Regulation

Jan B. Pietzsch, Lauren M. Aquino, Paul G. Yock, M. Elisabeth Paté-Cornell, John H. Linehan
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Technology Review
J. Med. Devices. December 2007, 1(4): 283–292.
https://doi.org/10.1115/1.2812429
Published Online: October 19, 2007
... and effective. biomedical equipment quality control regulation reviews risk analysis 14 03 2007 19 10 2007 2007 American Society of Mechanical Engineers ...
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Topics: Food and Drug Administration, Frequency-domain analysis, Medical devices, Safety, Risk, Design, Drugs