의료기기 사용적합성 평가기관의 운영기준에 관한 연구

Abstract

With the implementation of ISO 13485:2016 in Korea, usability evaluation documentation has become a mandatory requirement for GMP audits, leading to increased demand. To ensure the reliability of evaluation processes and minimize operational discrepancies across institutions, this study aims to establish standardized operational guidelines for medical device usability evaluation institutions. This study developed an operational status analysis framework and conducted a survey of 17 domestic medical device usability evaluation institutions to examine their operational practices. Based on the survey findings, standardized operational guidelines for usability evaluation institutions were formulated. The analysis of the operational status of domestic usability evaluation institutions revealed that most institutions have dedicated personnel for usability evaluations, as well as designated evaluation and observation rooms. Based on these findings, proposed operational standards were categorized into three key areas: personnel, facilities, and quality man- agement. For personnel, institutions must employ evaluators and observers, specifying their qualifications and roles. Regarding facilities and equipment, institutions should maintain separate evaluation and observation rooms, storage areas for medical devices, and document archives, while also ensuring proper equipment availability and scheduled maintenance. In terms of quality management, the proposed standards include documentation management practices such as maintaining records in physical archives or secure online servers. By establishing standardized operational guidelines for medical device usability evaluation institutions, this study contributes to enhancing consistency and reliability in usability evaluations. Furthermore, the proposed guidelines are expected to improve the overall quality of the domestic medical device industry and strengthen its global competitiveness.