Collect evidence in a summative evaluation (or human factors validation test) to show your product can be used safely and effectively in conditions of actual use.
A summative evaluation (or human factors validation test) is carried out at the end of development when the user interface has been finalised. Evidence is collected to show that the device can be used safely and effectively by intended users in the use environment.
All hazard-related use scenarios (or critical tasks) are evaluated, including information for safety. An adequate level of realism needs to be created to confidently make generalisations on device-use safety for conditions of actual use.
We are experts in designing and running summative studies. We can either run the full study ourselves or work in collaboration with your team. We prepare protocols, recruit participants, organise venues, collect data through observation and interviews, and develop reports.
Our summative evaluations are always carried out in accordance with IEC 62366-1:2015+AMD1:2020 and guidance from the FDA and MHRA. Since 2009 we have conducted over 20 summative evaluations across Europe and North America involving various types of devices.
