Free template (MS Word)
Periodic Summary Report (PSR) for Manufacturers of Medical Devices
Summarize related serious incidents and corrective actions through a simpler reporting process.
The Periodic Summary Report (PSR) applies to specific cases involving groups of common, well-documented serious incidents or field safety corrective actions with a known root cause. This template is aligned with the EU MDR and aims to simplify the reporting process.
This template helps you:
- Highlight investigation results
- Analyze current trends
- Show improvements compared with past performance
Prepared by Advisera experts to help you get started with EU MDR periodic summary reporting.
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