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identification of the persons who carried out the risk analysis

Discussion in 'ISO 14971 - Medical Devices Risk Management' started by newblues, Feb 5, 2016.

  1. newblues

    newblues New Member

    Feb 5, 2016
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    Section 4.1 of ISO14971(2007) requires identification of the persons and organization who carried out the risk analysis.
    Is it saying all the persons involved in the risk management should be recorded? Or, is it OK to record only a few persons who played major role in the risk management?
    Thank you.

  2. Pads38

    Pads38 Member

    Aug 6, 2015
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    As the person signing the final risk report I am identified, along with a counter-signature from someone senior, who has reviewed the report.

    The latest report used published literature to provide objective evidence. The references were fully cited, with author details and publication details.

    Where the risk management process has involved a team of people I would be inclined to keep formal meeting minutes, with lists of attendance. These could form part of your "Device History File". But the full team list may not be needed in the final report.

    However, if you have used an "expert" to provide opinion I would ensure that full name and details are recorded. This would include some reasoning as to why this person should be considered to be "expert". This situation could apply when you are using the opinion of a respected clinician to, say, justify the level of residual risk.
  3. Marcelo Antunes

    Marcelo Antunes Active Member

    Jul 31, 2015
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    The requirement is only for the risk analysis, not the risk management or risk management report. The requirement is only to identify the person/persons which conduct the risk analysis (the first part of the RM process.
    Ronen E likes this.

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