Free template (MS Word)
Equivalence Table for Clinical Evaluation Usage
Document device equivalence and support MDR conformity using existing clinical data.
This template helps you:
- Demonstrate conformity with MDR safety and performance requirements
- Use existing clinical data from an equivalent device during clinical evaluation
- Reduce spending on additional clinical studies
- Clearly state differences between the devices
- Analyze how differences may affect safety and performance
- Include illustrations highlighting similarities and differences
Prepared by Advisera experts to help you get started with MDR clinical evaluation.
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