Non-functional requirements testing in the Medtech industry

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Although software testing is widely used during the software development phase of medical technologies (Medtech), there is no common ground regarding identification, separation, and testing of functional and non-functional requirements within the development cycle. The objective of this thesis was to implement a taxonomy for non-functional requirements within the Medtech industry, and to build an automated test framework including tests for non-functional requirements linked to user experience. The methodology used for the thesis was action research, iterated through a research, construction and a simulation phase for each test. Information gathered regarding test development was collected through interviews, documents, experience, and prior work. A taxonomy for identifying, separating, and prioritizing software requirements was developed. Further, an automated test framework was developed which included automated tests evaluating the reliability, performance, scalability, and portability of the software system. Two reliability tests were developed to evaluate the stability and placement of medical tools within the simulation. An additional test was developed evaluating the performance, scalability, and portability of the software system. It was shown that automated tests can detect and notify software developers and project managers with information regarding non-functional requirements of their software system. Although non-functional requirements often can be difficult to comprehend, the result within this thesis suggests that there is great value in identifying, classifying, and testing non-functional requirements within the Medtech software development cycle to secure a satisfied end-user.

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Requirements engineering, Non-functional requirements, Taxonomy, Software development, Medtech software, Automated testing, User experience

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