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Medical device software - Guidance on the application of ISO 14971 to medical device software

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Medical device software - Guidance on the application of ISO 14971 to medical device softwarePD IEC TR 80002 1 1: 2009 Medical device software. Guidance on the application of ISO 14971 to medical device software PD IEC TR 80002 1 1 is a technical report aimed at risk management practitioners who need to perform risk management when software is included in the medical device system, and at software engineers who need to understand how to fulfil the requirements for risk management addressed in ISO 14971. BS EN ISO 14971, recognized worldwide

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