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AAMI TIR80002-1:2009

Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device software
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AAMI TIR80002-1:2009

Medical device software—Part 1: Guidance on the application of ISO 14971 to medical device software

PUBLISH DATE 2016
AAMI TIR80002-1:2009
This technical document provides information useful for the performance of effective software risk management, as part of the overall risk management process for medical devices containing software. It does this in the context of ISO 14971:2007, Medical devices - Application of risk management to medical devices and in the context of ISO/IEC 62304:2006, Medical device software—Software life cycle processes.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number TIR80002-1
Publication Date May 1, 2016
Language en - English
Page Count 80
Revision Level
Supercedes
Committee
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