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RegMed 2018 Vol. 97 10 5. SaMD N41: Software as a Medical Device (SaMD): Clinical Evaluation (2017) 6. Software as a Medical Device (SaMD): Clinical Evaluation. Guidance for Industry and Food and Drug Administration Staff. Document issued on December 8, 2017. 7. GHTF SG5 N2R8:2007: Clinical Evaluation 8. GHTF SG3 N18:2010: Quality management system –Medical Devices – Guidance on corrective action and preventive action and related QMS processes

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