University of Limerick Institutional Repository

Configuration management process improvement for the medical device industry

DSpace Repository

Show simple item record

dc.contributor.author Mc Caffery, Fergal
dc.contributor.author Coleman, Gerry
dc.date.accessioned 2012-06-05T15:17:00Z
dc.date.available 2012-06-05T15:17:00Z
dc.date.issued 2006
dc.identifier.citation Mc Caffery, F etal (2006) "Configuration management process improvement for the medical device industry," in 6th International SPICE Conference on Process Assessment and Improvement en_US
dc.identifier.uri http://hdl.handle.net/10344/2248
dc.description peer-reviewed en_US
dc.description.abstract This paper outlines how the goals, practices and capability levels for the configuration management (CM) process area within a software process improvement (SPI) framework have been developed. This framework addresses an opportunity to integrate the regulatory issues and SPI mechanisms so as to achieve improvements that are critical to the development of software for medical devices [1]. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (FDA) [2] (US requirement), and the European Commission under its Medical Device Directives (MDD) [3] (CE marking requirement) is achieved. Integrated into the design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a design history file. Design history illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components. en_US
dc.language.iso eng en_US
dc.relation.ispartofseries 6th International SPICE Conference on Process Assessment and Improvement;
dc.subject configuration management en_US
dc.subject software engineering en_US
dc.subject SPI en_US
dc.subject medical devices en_US
dc.title Configuration management process improvement for the medical device industry en_US
dc.type info:eu-repo/semantics/conferenceObject en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.contributor.sponsor SFI en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US


Files in this item

This item appears in the following Collection(s)

Show simple item record

Search DSpace


Browse

My Account

Statistics