Mockups and check list-based GUI reviews for diagnostic software

Many regulations and standards have to be applied when developing medical devices and their software components. All these legislations directly influence the operation of software development, or demand for traceable documentation of all decisions made during the developmental process. In this regard, the fulfilment of IEC 62366 – Medical devices – Application of usability engineering to medical devices has to be ensured, to avoid that utilization errors or misuse of functionalities might risk patients health, and to develop viable countermeasures, too. Dependent on the situation, different techniques of Usability-Engineering are applied. To illustrate the applications that have to be investigated, persona or utilisation scenarios are created. This enables the identification of intended and unintended operating errors. The resulting countermeasures are fed in the continuing development and are carefully documented in compliance with relevant standards.