|
KMID : 1137820230440020099
|
|
의공학회지
2023 Volume.44 No. 2 p.99 ~ p.108
|
|
|
Software Risk Management and Cyber Security for Development of Integrated System Remotely Monitoring and Controlling Ventilators
|
|
Chung Ji-Yong
Kim You-Rim
Jang Won-Seuk
|
|
|
Abstract
|
|
|
|
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.
|
|
|
KEYWORD
|
|
|
Medical device software, Central remote monitoring, Risk management, Cybersecurity, Software validation
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|