Usability

Usability is an essential consideration in the design of a medical device. It is a very important characteristic of the device operating profile and should be conducted in accordance with IEC 62366 series.

We provide specialised support in the preparation of usability studies relating to medical devices to ensure patient safety and clinical performance.

We provide the test protocol and the device usability evaluation report.

The usability process is performed along with the risk analysis, in order to estimate and evaluate the risks associated with the use, errors of use and ergonomic characteristics of the device, with the aim of reducing these as much as possible.

We provide usability evaluation both in the preliminary phases of the device design and in the advanced phases.