The risk management system should be carefully aligned with and reflected in the clinical evaluation for the device, including the clinical risks to be addressed as part of clinical investigations, clinical evaluation and post-market clinical follow up.
Ba cheart an córas bainistithe rioscaí a ailíniú go cúramach leis an meastóireacht chliniciúil ar an bhfeiste agus ba cheart é sin a léiriú sa mheastóireacht, lena n-áirítear na rioscaí cliniciúla nach mór aghaidh a thabhairt orthu mar chuid d'imscrúduithe cliniciúla, den mheastóireacht chliniciúil agus den mheasúnú leantach cliniciúil iarmhargaidh.