El fabricante del SW debe aplicar la norma IEC62366 para verificar requisitos de usabilidad

Clasificación del SW según MDR
La regla 11 del MDR y la guía MDCG2019-11 El MDR en su Anexo VIII
El fabricante del SW debe aplicar la norma IEC62366 para verificar requisitos de usabilidad
La regla 11 del MDR y la guía MDCG2019-11 El MDR en su Anexo VIII
El MDR ha introducido nuevos requisitos para el Post Market Clinical Follow-up (PMCF). Introducción Según
Los fabricantes de Software como Producto Sanitario o SaMD (Software as Medical Device) tienen que
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