Free template (MS Word)
Field Safety Corrective Action (FSCA) Report
Document corrective actions clearly for authority assessment and monitoring.
Under the EU MDR, medical device manufacturers must report field safety corrective actions to the authorities using the Field Safety Corrective Action (FSCA) Report. The report contains the information authorities need to assess and monitor the implemented actions.
This template helps you:
- Assess the basic cause against the device risk analysis
- Explain whether the issue falls within applicable limiting values
- Provide evidence of preventive and corrective actions taken to prevent comparable incidents
Prepared by Advisera experts to help you get started with EU MDR field safety corrective action reporting.
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