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Risk Management Process

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by QA Bee, Jan 5, 2016.

  1. QA Bee

    QA Bee Member

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    How do you define a Risk Management Process?

    I am in process of writing a procedure and Risk Management report and hitting road blocks on how to describe each steps.

    Anyone has any SOP and form template that they would like to share?

    Thanks
     
  2. Ronen E

    Ronen E Well-Known Member

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    If you follow ISO 14971, coming up with a risk management process / procedure should be quite straightforward.

    Cheers,
    Ronen.
     
  3. Pads38

    Pads38 Member

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    As Ronen says, there is no better guide than ISO 14971.

    Start at clause 3.1, 3.4 and Annex F.
     
  4. William Gray

    William Gray New Member

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  5. QA Bee

    QA Bee Member

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    Thank you so much everyone for pointers.

    I will try going thru it again.
     

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