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AAMI TIR32:2004 (AAMI TIR 32:2004)

Medical device software risk management

Effective Software Risk Management is a significant part of the overall risk management process for medical devices containing software. This Technical Information Report (TIR) provides information useful to performing effective software risk management.


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


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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.

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