The quality features of our Usability Validations are: to recruit the right user groups, create the right test setting, take risk management into account and formulate acceptance criteria. We validate the suitability for use of the medical product itself, together with accompanying materials such as instructions for use and training documents.
In the test session, the moderator takes the user through the process and the observer makes a note of everything that happens that is of relevance to the test.
When the Usability Tests are analyzed, the individual results are precisely classified according to the acceptance criteria.
We provide advice on how to process the results in such a way that nothing more stands in the way of an approval by the relevant official authority.
«Incidentally, we don’t just observe; we also design.»