Practical software testing for an FDA-regulated environment

dc.contributor.advisorKhurshid, Sarfrazen
dc.contributor.committeeMemberPerry, Dewayne E.en
dc.creatorVadysirisack, Pang Lithisayen
dc.date.accessioned2012-02-27T15:16:44Zen
dc.date.available2012-02-27T15:16:44Zen
dc.date.issued2011-12en
dc.date.submittedDecember 2011en
dc.date.updated2012-02-27T15:16:54Zen
dc.descriptiontexten
dc.description.abstractUnlike hardware, software does not degrade over time or frequency use. This is good for software. Also unlike hardware, software can be easily changed. This unique characteristic gives software much of its power, but is also responsible for possible failures in software applications. When software is used within medical devices, software failures may result in bodily injury or death. As a result, regulations have been imposed on the makers of medical devices to ensure their safety, which includes the safety of the devices’ software. The U.S. Food and Drug Administration requires establishment of systems and control processes to ensure quality devices. A principal part of the quality assurance effort is testing. This paper explores the unique role of software testing in the design, development, and release of software used for medical devices and applications. It also provides practical, industry-driven guidance on medical device software testing techniques and strategies.en
dc.description.departmentElectrical and Computer Engineeringen
dc.format.mimetypeapplication/pdfen
dc.identifier.slug2152/ETD-UT-2011-12-4719en
dc.identifier.urihttp://hdl.handle.net/2152/ETD-UT-2011-12-4719en
dc.language.isoengen
dc.subjectSoftwareen
dc.subjectSoftware testingen
dc.subjectFDAen
dc.subjectRegulationsen
dc.subjectMedical devicesen
dc.subjectSoftware design lifecycleen
dc.subjectRegulatory complianceen
dc.titlePractical software testing for an FDA-regulated environmenten
dc.type.genrethesisen
thesis.degree.departmentElectrical and Computer Engineeringen
thesis.degree.disciplineElectrical and Computer Engineeringen
thesis.degree.grantorUniversity of Texas at Austinen
thesis.degree.levelMastersen
thesis.degree.nameMaster of Science in Engineeringen
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