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Performance Evaluation

Performance Evaluation Report Template

4.6 (28 reviews)

Complete template for documenting Performance Evaluation results per Annex XIII Part A. Includes sections for data analysis, conclusions, and ongoing evaluation requirements. Aligned with MDCG guidance on performance evaluation.

IVDR Articles Covered:

Article 56Annex XIII

What's Included:

  • Structured report format per MDCG guidance
  • Data summary and analysis sections
  • Conclusions and acceptance criteria
  • Literature review documentation
  • Post-market performance evaluation planning
File Formats

DOCX, PDF

License

Single organization license

€199.00Instant download after purchase

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