Software Clinical Evaluation Procedure
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR (EU) 2017/745 Compliant
- MS Word Format
- Digital Content - Instant Download
Software Clinical Evaluation ProcedureThe 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 - OverviewClinical 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. Software Clinical Evaluation Procedure - ComplianceThe Software Clinical Evaluation Procedure complies with ISO 13485:2016, FDA 21 CFR Part 820, and MDR (EU) 2017/745.
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