by Knowhownow fieldwork | May 16, 2019 | Education
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, ...
by Knowhownow fieldwork | Jun 5, 2018 | Education
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....
by Knowhownow fieldwork | May 29, 2018 | Education
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)...