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ANSI/AAMI/IEC TIR80002-1:2009

Medical device software - Part 1:Guidance on the application of ISO14971 to medical device software

Provides guidance for the application of the requirements contained in ISO 14971:2007, Medical devices - Application of risk management to medical devices to MEDICAL DEVICE SOFTWARE with reference to IEC 62304:2006, Medical device software - Software life cycle processes.


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Association for the Advancement of Medical Instrumentation [aami]


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