Software Clinical Evaluation Procedure

The Software Clinical Evaluation Procedure governs the clinical evaluation activities, including the assessment and analysis of the clinical safety, effectiveness and performance, of the Software.

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Software Clinical Evaluation Procedure

The Software as a Medical Device Clinical Evaluation Procedure governs the clinical evaluation activities, including the assessment and analysis of the clinical safety, effectiveness and performance, of Software.

Software Clinical Evaluation Procedure - Overview

Clinical evaluation is a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a SaMD in order to generate clinical evidence verifying the clinical association and the performance metrics of software when used as intended. The Software Clinical Evaluation Procedure provides guidance on three distinct aspects: (1) Valid Clinical Association; (2) Analytical Validation, and (3) Clinical Validation activities. The procedure includes definition of responsibilities, evaluation process flow and methods of generating and assessing relevant evidence used in each area of clinical evaluation.