Software Clinical Evaluation Procedure
SKU: SOP 7-044
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 as a Medical Device (SaMD).
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR (EU) 2017/745 Compliant
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