Cerba Research is committed to helping you identify potential user errors of your Medical Device.
What is Usability Engineering?
The usability of IVDs is an important aspect for patient safety, for the efficient application of the devices, as well as for satisfied users. IVD manufacturers are responsible for all necessary activities relating to usability in accordance with IEC 62366-1 for all IVD medical devices.
The usability studies, also called summative evaluation, must be conducted to reveal user errors. In context, real users interact with prototypes or pilot batches to assess the learning and memory conduciveness, simplicity of use, efficiency, and/or attractiveness for the user. Usability studies may be conducted in a laboratory environment, in a simulated environment, or in the real environment of the intended use.
How can Cerba Xpert support you with usability requirements?
Combined with its expertise and experience, Cerba Expert may capitalize its accessibility to devices, adequate user profile and other required resources like qualified biospecimen or testing environment to successfully design usability engineering activities to our customers.
Reach out to our team of experts and discover how we can help you advance your clinical trial.Contact Us