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dc.contributor.authorRuiz, Alejandra
dc.contributor.authorBarbosa, Paulo
dc.contributor.authorMedeiros, Yang
dc.contributor.authorEspinoza, Huascar
dc.date.accessioned2016-06-17T11:15:23Z
dc.date.available2016-06-17T11:15:23Z
dc.date.issued2015-11-25
dc.identifier.citationComputer Safety, Reliability, and Security / Volume 9337 of the series Lecture Notes in Computer Science / pp. 183-196 / 2015 / 34th International Conference on Computer Safety, Reliability, and Security (SAFECOMP)en
dc.identifier.isbn978-3-319-24255-2; 978-3-319-24254-5en
dc.identifier.urihttp://hdl.handle.net/11556/254
dc.description.abstractMedical devices are safety-critical systems that must comply with standards during their development process because of their intrinsic potential of producing harms. Although the existing trend of an increasing complexity of medical hardware and software components, very little has been done in order to apply more mature safety practices already present on other industrial scenarios. This paper proposes a methodology to enhance the Model-Based System Engineering (MBSE) state-of-art practices from the safety perspective, encouraging the use of safety cases and providing guidance on how to show the correspondent traceability for the development artifacts. We illustrate our methodology and its usage in the context of an industrial Automated External Defibrillator (AED). We suggest that medical device industry could learn from other domains and adapt its development to take into account the hazards and risks along the development, providing more sophisticated justification, as, for example, the impact of design decisions.en
dc.language.isoengen
dc.publisherSPRINGER INT PUBLISHING AG, GEWERBESTRASSE 11, CHAM, CH-6330, SWITZERLANDen
dc.titleSafety Case Driven Development for Medical Devicesen
dc.typeconferenceObjecten
dc.identifier.doi10.1007/978-3-319-24255-2_14en
dc.isiYesen
dc.rights.accessRightsembargoedAccessen
dc.subject.keywordsSafety caseen
dc.subject.keywordsMedical deviceen
dc.subject.keywordsSoftware development methodologyen
dc.subject.keywordsAutomated external defibrillatorsen


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