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.
|