User-Centered Formative Evaluation of Cognitive Rehabilitation Software: Cognitive Walkthrough and System Usability Scale Study

The combined use of CW and the SUS enabled the identification of both objective and perceived usability challenges in the cognitive rehabilitation software. Findings emphasize the importance of user-centered design and formative evaluation in the early stages of software development. Recommendations such as improving information visibility, reducing unnecessary steps, and enhancing system feedback may contribute to safer and more effective digital cognitive interventions. However, given the small and homogeneous participant sample and the controlled test environment, these findings should be interpreted as preliminary. This study highlights the practical application of the IEC 62366-1 framework in evaluating software as a medical device and demonstrates its utility in guiding iterative user experience and UI improvements in cognitive rehabilitation contexts.