Browsing by Author "Raatikainen, Marko"

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.