• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.15 no.2
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• pp.164-177
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• 2022

Medical device usability evaluation refers to the evaluation of medical devices through actual users before the final prototype production is completed. IEC 62366, one of the international safety standards for electronic medical devices, is a standard that must be applied to obtain medical device licenses in major advanced countries such as Europe and the United States. In Korea, through the Ministry of Food and Drug Safety's notice, from January 2021, sequential application by grade has been implemented. In this study, 15 participant specialists were recruited through the Incheon G University Hospital Medical Device Convergence Center for formative evaluation during user suitability evaluation of the focused ultrasound stimulation system being developed by Icleo Co., Ltd., and the test was conducted through joint scenario development. . In the result of task performance, the performance rate was 90.67%, and after the completion of the performance, 86.67% of 'Easy user interface' and 94% of 'Identification/Readability/Understanding of information' questions in the participant survey results analysis by question. The response rate was above average.