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Group logo of Full pdf: IEC /TR 80002-1:2009 - Medical device software — Part 1: Guidance on the application of IS

Full pdf: IEC /TR 80002-1:2009 – Medical device software — Part 1: Guidance on the application of IS

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Download link: ==> IEC /TR 80002-1:2009 – Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software pdf
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IEC/TR 80002-1:2009 provides guidance on the application of ISO 14971, a standard for risk management of medical devices, specifically tailored to address considerations and best practices when applying this framework to medical device software.

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