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Should NCMR or rejection be part of DHR?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Crossi89, Apr 18, 2024.

  1. Crossi89

    Crossi89 New Member

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    If a device has not been released from production, and fails final test, then is reworked (not a deviation) should the failed test and related NCMR be apart of or referenced in the DHR?
     
    Crossi89, Apr 18, 2024
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