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annex Za (Risk assessment)

Discussion in 'EU Medical Device Regulations' started by khamec, Jun 13, 2016.

  1. khamec

    khamec New Member

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    Dear All
    Can you give me the guidance of Risk assessment ( including annex Za) for medical device .
    due to complete Risk analysis of every technical file for medical device

    Thanks for all
     
  2. yodon

    yodon Active Member

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    It sounds like you're asking for a complete overview of 14971:2012. If that's the case, it's far too broad a subject to cover in a discussion board. Do you have a copy of 14971:2012? If not, purchase one (it's copyright material) and read through it. You can then ask specific questions regarding application.
     
    Atul Khandekar and Bev D like this.

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