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Software process improvement for the medical industry.
Closed Published by McCaffery F, Donnelly P, McFall D, Wilkie FG November 20th, 2005 in PubMed Medical Devices, Stud Health Technol Inform, Regulatory Affairs |
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Software process improvement for the medical industry.
Stud Health Technol Inform. 2005;117:117-24
Authors: McCaffery F, Donnelly P, McFall D, Wilkie FG
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.
PMID: 16282661 [PubMed - in process]
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