Development Life Cycle-Based Association Analysis of Requirements for Risk Management of Medical Device Software

KIPS Transactions on Software and Data Engineering, Vol. 6, No.12, pp.543-548, December 2017
10.3745/KTSDE.2017.6.12.543, Full Text

Abstract

In recent years, the importance of the safety of medical device software has been emphasized because of the function and role of the software among components of the medical device, and because the operation of the medical device software is directly related to the life and safety of the user. To this end, various standards have been set up that provide activities that can effectively ensure the safety of medical devices and provide their respective requirements. The activities that standards provide to ensure the safety of medical device software are largely divided into the development life cycle of medical device software and the risk management process. These two activities should be concurrent with the development process, but there is a limitation that the risk management requirements to be performed at each stage of the medical device software development life cycle are not classified. As a result, developers must analyze the association of standards directly to develop risk management activities during the development of medical devices. Therefore, in this paper, we analyze the relationship between medical device software development life cycle and risk management process, and extract risk management requirement items. It enables efficient and systematic risk management during the development of medical device software by mapping the extracted risk management requirement items to the development life cycle based on the analyzed associations.


Statistics

Show / Hide Statistics

Statistics (Cumulative Counts from October 15, 2016)

Multiple requests among the same browser session are counted as one view. If you mouse over a chart, the values of data points will be shown.


Cite this paper

[KIPS Transactions Style]
D. Kim, Y. Park, and J. Lee, "Development Life Cycle-Based Association Analysis of Requirements for Risk Management of Medical Device Software," KIPS Transactions on Software and Data Engineering, Vol.6, No.12, pp.543-548, 2017, DOI: 10.3745/KTSDE.2017.6.12.543.

[IEEE Style]
DongYeop Kim, Ye-Seul Park, and Jung-Won Lee, "Development Life Cycle-Based Association Analysis of Requirements for Risk Management of Medical Device Software," KIPS Transactions on Software and Data Engineering, vol. 6, no. 12, pp. 543-548, 2017. DOI: 10.3745/KTSDE.2017.6.12.543.

[ACM Style]
Kim, D., Park, Y., and Lee, J. 2017. Development Life Cycle-Based Association Analysis of Requirements for Risk Management of Medical Device Software. KIPS Transactions on Software and Data Engineering, 6, 12, (2017), 543-548. DOI: 10.3745/KTSDE.2017.6.12.543.