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John Walz AAMI Quality Standards Tuesday, July 28, 2009

AAMI Technical Information Report IEC TR 80002-1 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software. John Walz AAMI Quality Standards Tuesday, July 28, 2009. IEC TR 80002-1.

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John Walz AAMI Quality Standards Tuesday, July 28, 2009

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  1. AAMI Technical Information ReportIEC TR 80002-1Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software John Walz AAMI Quality Standards Tuesday, July 28, 2009

  2. IEC TR 80002-1 • Technical report for the understanding ISO 14971:2007 in a software perspective • Follow the structure of ISO 14971:2007 and guidance is provided for each RISK MANAGEMENT activity in relation to software. • ISO 14971:2007, Medical devices— Application of risk management • IEC 62304:2006, Medical device software—Software life cycle processes

  3. IEC TR 80002-1TableofContents

  4. Requirements for documentation to be included in the RISK MANAGEMENT FILEin addition to ISO 14971:2007 requirements

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