Conference Agenda

The Med & Health working group invites all UUX professionals to discuss the topic of medical devices and their special features in relation to UUX. Some members of the working group have created a poster that illustrates the UUX process for medical devices and combines it with DIN EN ISO 9241-210. Using the poster, we as professionals can show which activities are useful and necessary to bring a medical device to market that has been designed to be human-centred and meets the regulatory requirements for avoiding operating errors.
Our second topic is a perennial favourite in the UUX community: how many test participants do we need for usability tests in order to obtain reliable statements about safe and error-free operation? The topic is of particular importance for medical devices, as authorities and notified bodies check whether usability engineering has been carried out in accordance with the state of the art. The standardisation and also the guidelines of the authorities do not provide any binding specifications or helpful recommendations. Nothing is specified for the European market and each notified body decides according to its own standards. For this reason, we want to venture an expert statement that enables pragmatic implementation on the one hand and a well-founded argumentation from the UUX point of view towards authorities and notified bodies on the other.
Finally, we want to collect topics together with you that should be dealt with in the Med & Health working group.