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Registries for Real world data for FDA submission/PMCF studies for EU

  • 1.  Registries for Real world data for FDA submission/PMCF studies for EU

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jan-2022 09:11
    This message was posted by a user wishing to remain anonymous

    Hello forum members ,

    Has anybody created registries for gathering data for approved devices for new uses. How do we go about this activity ?

    tnx


  • 2.  RE: Registries for Real world data for FDA submission/PMCF studies for EU

    Posted 11-Feb-2022 09:57
    Dear Ano,

    I am not sure that I understand well your question, but may be this BSI web link can help you :

    https://www.bsigroup.com/globalassets/localfiles/zh-tw/medical_device/document/bsi-smart-support-post-market-surveillance.pdf

    Best Regards



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