IFU testing Knowhownow



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,  it could be stated that the instructions were safe.

The IfU readability test was performed in Boston amongst 24 Americans.
Due to cultural differences betwwe the EU and USA and regulatory requirements it was was decided to perform the test amongst American residents.