Usability for medical devices

To validate the suitability for use in line with the IEC 62366 standards, we conduct Usability Tests with doctors and specialist medical staff.

High quality standards

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. ​

Usability Testing

During observation periods, our partners from Product Management, Regulatory Affairs and Quality Management monitor the Usability Tests live. We moderate the tests, compile summaries, conduct evaluations and integrate the results into our customers’ documents.

Our approach

One-on-one interviews

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.

Precise evaluation

When the Usability Tests are analyzed, the individual results are precisely classified according to the acceptance criteria.

Results processing

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.

Placing on the market

The product development process is completed by a professional validation, and the product can be launched on the market. At the same time, the foundation is laid for the correct market monitoring.

«Incidentally, we don’t just observe; we also design.»

Felix Petermann

UX Designer