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About This Item

 

Full Description

Valuable checklist also available to assist with compliance to this standard.

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

  1. BS EN ISO 14971:2019

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    Medical devices. Application of risk management to medical devices

    • Most Recent
  2. BS EN ISO 14971:2012


    Medical devices. Application of risk management to medical devices

    • Historical Version
  3. BS EN ISO 14971:2009


    Medical devices. Application of risk management to medical devices

    • Historical Version
  4. BS EN ISO 14971:2007


    Medical devices. Application of risk management to medical devices

    • Historical Version
  5. BS 05/30140005 DC


    BS EN ISO 14971 ED 2. Medical devices. Application of risk management to medical devices

    • Historical Version
  6. BS EN ISO 14971:2001


    Medical devices. Application of risk management to medical devices

    • Historical Version
  7. BS EN 1441:1998


    Medical devices. Risk analysis

    • Historical Version