McCaffery, F., Burton, J., Casey, V. and Dorling, A., 2010. Software Process Improvement in the Medical Device Industry. In: Laplante, P. A., ed. Encyclopedia of Software Engineering. London: Taylor and Francis. (In Press)
Full text not available from this repository.
This chapter considers medical device software development which takes place in a regulated environment. Research has shown that medical device regulations cannot be completely satisfied by generic software process improvement models. The development of a software process assessment model (Medi SPICE) specifically for the medical device industry through extending relevant practices from ISO/IEC 15504-5 is presented. Medi SPICE consists of a Process Reference Model and a Process Assessment Model. The Medi SPICE Process Assessment Model can be used to perform conformant assessments of the software process capability of medical device suppliers in accordance with the requirements of ISO/IEC 15504-2: 2003. The Medi SPICE Process Assessment Model is based on ISO/IEC 15504-5: 2006 but can also provide coverage of additional software development practices that are required to achieve regulatory compliance within the medical device industry.
|Item Type:||Book Section|
|Number of Pages:||1522|
|Uncontrolled Keywords:||Software Process Improvement, Medical Device Industry, SPICE, ISO/IEC 15504-5, FDA, Regulated Software Development, Medi SPICE|
|Subjects:||Generalities > Computer Science and Informatics|
|Group:||School of Design, Engineering & Computing > Creative Technology Research Group|
|Deposited By:||Dr Valentine Casey LEFT|
|Deposited On:||16 Dec 2009 19:59|
|Last Modified:||07 Mar 2013 15:19|
|Repository Staff Only -|
|BU Staff Only -|
|Help Guide -||Editing Your Items in BURO|