Browse > Article
http://dx.doi.org/10.3745/KTSDE.2017.6.12.543

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

Kim, DongYeop (아주대학교 전자공학과)
Park, Ye-Seul (아주대학교 전자공학과)
Lee, Jung-Won (아주대학교 전자공학과)
Publication Information
KIPS Transactions on Software and Data Engineering / v.6, no.12, 2017 , pp. 543-548 More about this Journal
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.
Keywords
Development Life Cycle; Medical Device Software; Medical Device Risk Management; Item Relevance Analysis;
Citations & Related Records
연도 인용수 순위
  • Reference
1 Y. Bayon, M. Bohner, D. Eglin, P. Procter, R. G. Richards, J. Weber, and D. I. Zeugolis, "Innovating in the medical device industry-challenges & opportunities ESB 2015 translational research symposium," Journal of Materials Science: Materials in Medicine, Vol.27, No.9, p.144, 2016.   DOI
2 IEC 60601-1:2005, Medical electrical equipment-Part1: General requirements for basic safety and essential performance, 2005.
3 ISO 14971, Medical devices-Application of risk management to medical devices, 2000.
4 IEC 62304, Medical device software - Software life cycle processes.
5 D. Flood, F. McCaffery, V. Casey, R. McKeever, and P. Rust, "A roadmap to ISO 14971 implementation," Journal of Software: Evolution and Process, Vol.27, No.5, pp.319-336, 2015.   DOI
6 J. Burton, F. McCaffery, and I. Richardson, "A risk management capability model for use in medical device companies," Proceedings of the 2006 International Workshop on Software Quality. ACM, 2006.
7 OD-2044 Ed. 2.2. - Evaluation of Risk Management in Medical electrical equipment according to the IEC 60601-1 & IEC/ISO 80601-1 Series of Standards. 2013.
8 Y. M. Kim, S. H. Sim, H. C. Woo, and J. C. Lee, "On the Integration of Systems Engineering and Systems Safety Processes in the Development of Unmanned Aerial Vehicles for Improved Safety," Proceedings of the institute of electronics engineerings of Korea, pp.1985-1988, 2012.
9 J. H. Yoon, J. C. Lee, and S. H. Hong, "A Study on Integrated SE Process for the Development of the Railway Systems with Safety Assessment Include," Journal of the Korean Society for Railway, Vol.10, No.4, pp.438-443, 2007.
10 M. Lepmets, P. Clarke, F. McCaffrey, and A. Finnegan, "Development of a process assessment model for medical device software development," EuroSPI, 2014.