Clariscience offers companies specialised support in setting up usability studies for medical devices and IVDs. In relation to the specific device, Clariscience will develop with the company the best usability evaluation strategy to meet regulatory requirements, making the best use of available data and optimising testing activities.
Clariscience will prepare the test protocol, also in collaboration with a specialised test centre, and, having received the raw data from the laboratory, the report evaluating the usability of the device, commenting in consultation with the Company’s staff on any deviations that may have occurred.