s checks conducted, and designate a final evaluation of risk if different from the initial evaluation.РThe report should also contain the results of the recall, including how many units were recovered,Р how many units were not recovered (due to destruction, implantation or voluntary detention for reconditioning), and how many units from each consignee were corrected (modified, repaired or retrofitted).РFinally, the firm should report on the results of its plan to resolve or prevent recurrences of the problem by such measures as changing the product design, introducing a new sterility procedure or adding a step to the quality control process.РDocument and Record ConcernedР6.1 Canadian Medical Devices RegulationР6.2 Guidance for Medical plaint Handling and RecallsР6.plaint handling procedure
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