Author:
Özcan-Top Özden,McCaffery Fergal
Publisher
Springer International Publishing
Reference24 articles.
1. IEC 2006. IEC 62304: Medical Device Software - Software Life-Cycle Processes
2. ISO 2003. ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
3. ISO 2009. ISO 14971 - Medical Devices - Application of Risk Management to Medical Devices
4. Lepmets, M., Clarke, P., McCaffery, F., Finnegan, A., Dorling, A.: Development of MDevSPICE®–the medical device software process assessment framework. J. Softw. Evol. Process 27(8), 565–572 (2015)
5. Lepmets, M., Mc Caffery, F., Clarke, P.: Piloting MDevSPICE: the medical device software process assessment framework. In: Proceedings of the 2015 International Conference on Software and System Process, pp. 9–16. ACM (2015)