인공호흡기 원격 통합 모니터링 및 제어 시스템 개발을 위한 소프트웨어 위험관리 및 사이버보안 (Software Risk Management and Cyber Security for Development of Integrated System Remotely Monitoring and Controlling Ventilators)

서지정보

· 발행기관 : 대한의용생체공학회
· 수록지 정보 : 의공학회지 / 44권 / 2호 / 99 ~ 108페이지
· 저자명 : 정지용, 김유림, 장원석

초록

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential haz- ards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have seri- ous consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk man- agement and cybersecurity application.

영어초록

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential haz- ards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have seri- ous consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk man- agement and cybersecurity application.

참고자료

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