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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.

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Association for the Advancement of Medical Instrumentation [aami]

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