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Performance Evaluation
Clinical Evidence Report Template
4.5 (19 reviews)
Template for documenting clinical evidence per IVDR Annex XIII Part A Section 1.2. Suitable for Class C and D devices requiring clinical performance studies documentation.
IVDR Articles Covered:
Article 56Article 57Annex XIII
What's Included:
- Clinical performance study documentation
- Literature-based evidence compilation
- Diagnostic sensitivity/specificity reporting
- Reference to CPS requirements
- NB submission ready format
File Formats
DOCX, PDF
License
Single organization license
€189.00Instant download after purchase
Instant digital delivery • Money-back guarantee
