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Reliable Design Of Medical Devices - 9780824723750

Un libro in lingua di Fries Richard C. edito da Taylor & Francis, 2006

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This text by Fries (certified as a reliability engineer by the American Society for Quality) is designed to provide a practical approach to the formation and operation of a reliability assurance program for the development of medical devices. He first introduces the basics of reliability engineering and failures, next moving to a description of domestic and international device standards and regulations, placing particular emphasis on Federal Drug Administration regulations, the medical device directives, and the quality system regulation. The specification of a medical device is discussed in a section that covers the definition of medical device, establishment of product requirements, safety and risk analysis, liability, and intellectual property. The discussion then moves to design, with coverage of axiomatic and robust design, hardware and software design, software coding, the use of metric, and human factors. Verification and validation is then discussed and the volume concludes with a consideration of manufacturing as a continuation of the product development process. Annotation ©2006 Book News, Inc., Portland, OR (booknews.com)

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