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About This Item
Full Description
Recognized by regulatory authorities in the US, Canada, Europe and more, this international standard helps medical device manufacturers establish, document and maintain a systematic risk management process across all phases of the lifecycle of a medical device. Use of the standard helps streamline the regulatory processes that enable entry to selected markets.
Document History
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BS EN ISO 14971:2019+A11:2021
Medical devices. Application of risk management to medical devices- Most Recent
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BS EN ISO 14971:2019
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Medical devices. Application of risk management to medical devices- Historical Version
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BS EN ISO 14971:2012
Medical devices. Application of risk management to medical devices- Historical Version
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BS EN ISO 14971:2009
Medical devices. Application of risk management to medical devices- Historical Version
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BS EN ISO 14971:2007
Medical devices. Application of risk management to medical devices- Historical Version
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BS 05/30140005 DC
BS EN ISO 14971 ED 2. Medical devices. Application of risk management to medical devices- Historical Version
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BS EN ISO 14971:2001
Medical devices. Application of risk management to medical devices- Historical Version
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BS EN 1441:1998
Medical devices. Risk analysis- Historical Version