Title :
A software process improvement lifecycle framework for the medical device industry
Author :
McCaffery, F. ; McFall, D. ; Donnelly, P. ; Wilkie, F.G. ; Sterritt, R.
Author_Institution :
Centre for Software Process Technol., Northern Ireland, UK
Abstract :
This paper describes a software process improvement (SPI) framework to ensure regulatory compliance for the software developed in medical devices. The software framework introduced here (known as MedeSPI - medical devices software process improvement) will address an opportunity to integrate the regulatory issues and process improvement mechanisms in order to achieve improved software processes.
Keywords :
biomedical equipment; software development management; software process improvement; medical device industry; regulatory compliance; software development management; software process improvement; Computer industry; Ferroelectric films; ISO standards; Ice; Nonvolatile memory; Positron emission tomography; Production; Random access memory;
Conference_Titel :
Engineering of Computer-Based Systems, 2005. ECBS '05. 12th IEEE International Conference and Workshops on the
Print_ISBN :
0-7695-2308-0
DOI :
10.1109/ECBS.2005.13
