Field Safety Corrective Action (FSCA) Report

Download a free template (MS Word)

According to EU MDR manufacturers of medical devices must report field safety corrective actions to the authorities using the Field Safety Corrective Action (FSCA) Report. The FSCA Report contains all the necessary information for the authorities to assess and monitor the implemented actions.

This Field Safety Corrective Action (FSCA) Report helps manufacturers to:

  • Assess the basic cause against the risk analysis of the device
  • Provide arguments as to whether it falls within the applicable limiting values
  • Provide evidence of which preventive and/or corrective actions are being taken to prevent comparable incidents
Field Safety Corrective Action (FSCA) Report Under the EU MDR

 

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