Free template (MS Word)
Trend Report According to the EU MDR
Monitor non-serious incident trends and detect changes in device risk early.
This Trend Report simplifies monitoring non-serious incidents over time to identify changes in the benefit-risk analysis. Aligned with the EU MDR and ISO 13485, it provides a clear overview of potential increases in incident frequency or severity.
This template helps you:
- Meet regulatory requirements more easily
- Identify device problems early
- Support patient safety
- Avoid penalties or reputational damage
Prepared by Advisera experts to help you get started with EU MDR trend reporting.
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