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.
- Published:
- 02/15/2005
- ISBN(s):
- 1570202338
- Number of Pages:
- 55
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