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Performance Evaluation Plan Template
4.7 (34 reviews)
Structured template for creating Performance Evaluation Plans per IVDR Article 56 and Annex XIII Part A. Covers scientific validity, analytical performance, and clinical performance planning with methodology sections and acceptance criteria frameworks.
IVDR Articles Covered:
Article 56Annex XIII Part A
What's Included:
- Scientific validity assessment framework
- Analytical performance study design
- Clinical performance evaluation structure
- Literature search methodology
- Statistical considerations guidance
File Formats
DOCX, PDF
License
Single organization license
€179.00Instant download after purchase
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