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Efficient validation of tools used for medical software

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Title: Efficient validation of tools used for medical software
Author(s): Raatikainen, Marko
Contributor: University of Helsinki, Faculty of Science, Department of Computer Science
Discipline: Computer science
Language: English
Acceptance year: 2013
Abstract:
Regulations for medical device software require that some of the tools used in development are validated. This thesis takes a look at how the tool validation is done in GE Healthcare. Guidelines for more efficient tool validation are presented and tested out in practice. Final version of the guidelines are evaluated by 9 experts. According to the experts the initial validation done by following the guidelines will be somewhat faster, and subsequent validations will be significantly faster. However, the guidelines take advantage of automation, including automation of tests. More time is required, if the tools are unfamiliar, or if the tool being validated is not easy to test automatically.


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