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Historical
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]
Association for the Advancement of Medical Instrumentation [aami]