title: Software process improvement for the medical industry.
abstract: This chapter describes a software process improvement framework, structured to ensure regulatory compliance for the software developed in medical devices. 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 (US requirement), and the European Commission under its Medical Device Directives (CE marking requirement) is achieved.
authors.affiliation: Centre for Software Process Technologies, University of Ulster, Northern Ireland.
authors.forename: Fergal
authors.initials: F
authors.lastname: McCaffery
authors.forename: Peter
authors.initials: P
authors.lastname: Donnelly
authors.forename: Donald
authors.initials: D
authors.lastname: McFall
authors.forename: Frederick George
authors.initials: FG
authors.lastname: Wilkie
mesh_terms: D018795:Device Approval / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D011785:Quality Assurance, Health Care; D012985:Software Design