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AAMI TIR32:2004 (R2016)

Medical device software risk management

This AAMI technical information report provides information useful to performing effective software risk management, a significant part of the overall risk management process for medical devices containing software. It does this in the context of ANSI/AAMI/ISO 14971:2000, Medical devices - Application of risk management to medical devices, and in the context of ANSI/AAMI SW68:2001, Medical device software - Software life cycle processes.

Content Provider
Association for the Advancement of Medical Instrumentation [aami]

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Document History
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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.