be able to review and scientifically challenge the clinical data contained within the clinical evaluation, and any associated clinical investigations, and appropriately guide external clinical experts in the assessment of the clinical evaluation presented by the manufacturer;
bheith in ann na sonraí cliniciúla a fhaightear sa mheastóireacht chliniciúil, agus in aon imscrúduithe cliniciúla gaolmhara, a athbhreithniú agus a cheistiú go heolaíoch agus saineolaithe cliniciúla seachtracha a threorú go hiomchuí maidir le measúnú a dhéanamh ar na sonraí meastóireachta cliniciúla a chuireann an monaróir i láthair;