AAMI TIR32:2004/(R)2016 PDF
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.
