SOP Performance Evaluation
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Use this SOP Performance Evaluation template to systematically document and manage the evaluation of your in vitro diagnostic (IVD) device’s scientific validity, analytical performance, and clinical performance in compliance with IVDR Article 56 and Annex XIII. This template is essential for demonstrating conformity with relevant safety and performance requirements and should be completed during product development and updated continuously with post-market data. Completing this SOP ensures robust clinical evidence and supports your device’s technical documentation for regulatory submissions and ongoing compliance.