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Incident reporting

In case the Incident is reportable, we fill in, after agreement with the Manufacturer, an initial incident report according to the format given by the EU Vigilance Guidelines. We always request the final approval of the Manufacturer before sending the report. We follow up the actions of the Manufacturer such as historic lot analysis, incriminated product analysis, corrective action, etc... in order to write the final report. It is common that the concerned competent authority requests additional information before closing the file. Our large experience with severe incidents, very often due to the misuse of devices, allows us to protect manufacturers against negative decision from the national competent authorities.

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