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Developing Safe, Effective, and Reliable Medical Software

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Developing Safe, Effective, and Reliable Medical Software

Book by Association for the Advancement of Medical Instrumentation, 07/01/1991

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This publication is intended to acquaint users of computer-controlled medical devices and managers in the medical device industry with the issues involved in software development and with the basic principles of software quality assurance, hazard analysis, reliability testing, and design validation. It is not meant to be a "cookbook" on how to develop medical software, but rather a general introduction to important concepts.