IFU testing

IFU testing

    KHN conducts profound IfU testing in the USA. Recently KHN assisted with an FDA admission of a medical device. EU > USA. KHN delivered support for the FDA that the IfU was understandable to potential users. Like so, in addition to the user test, ...

RUT testdesign for IFU testing

RUT test design for IFU testingDuring the planned Marketing Authorisation Application (MAA) a Readability User Test was performed on the proposed package leaflet. The package leaflet met all  the predefined criteria. Still in the D150 LoQ requested IFU testing....

Leesbaarheidstest medische bijsluiter

Leesbaarheidstest Leesbaarheidstest: Begrijpelijk maken medische bijsluiters Check onze post over de leesbaarheidstest op Wikipedia Hoe jij kunt helpenContact! " Leesbaarheidstest. Sinds 2005 heeft het Europees Geneesmiddelenbureau (European Medicines Agency, EMeA)...