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Procedure for Clinical study

Discussion in 'EU Medical Device Regulations' started by Asquared, Jul 24, 2017.

  1. Asquared

    Asquared New Member

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    We are asked to have a procedure for clinical studies. Does anyone have an example of what the content of this procedure should be?
     
  2. yodon

    yodon Active Member

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    This isn't exactly in my wheelhouse but maybe it gets the discussion going. You may need to provide more context but there is a renewed emphasis on postmarket surveillance, which includes the need for some form of clinical evaluation (actually, the clinical evaluation should start before hitting the market). If you go to the MEDDEV guidance pae (http://ec.europa.eu/growth/sectors/medical-devices/guidance/#meddevs), there are several documents that may be applicable (again, depending on context):
    Maybe this gets you started or maybe it helps frame the conversation.
     
    Atul Khandekar likes this.
  3. Asquared

    Asquared New Member

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    We are in the middle of an audit for annex 2.3 and asked about if we have a top level procedure for clinical studies.
     
  4. indicator

    indicator Member

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    ISO 14155:2011:Clinical investigation of medical devices for human subjects -- Good clinical practice
     

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