Expert Review of Taxonomy based Testing: A Testing Framework for Medical Device Software

This paper details the expert review of a framework developed to implement a novel testing approach called taxonomy-based testing (TBT) for the medical device software domain. This framework proposes three approaches to implement TBT and has been validated by experts from the software testing industry and the medical device software domain. This paper details the results from the expert review. The expert review focused on validating the three approaches to TBT, the benefits of TBT to medical device software development, the accuracy of mappings of testing techniques from ISTQB and ISO/IEC/IEEE 29119-4:2015 to defects from a defect taxonomy, the integration of TBT into the standard test processes, ISTQB and ISO/IEC/IEEE 29119-2:2013 and the structure of the framework. The contribution of this paper is to reveal that (i) the framework is implementable in medical device software organisations that follow the IEC 62304:2006+A1:2015 software development process or that use standard test processes, (ii) using a defect taxonomy could standardise the application of experience-based approaches to software testing and (iii) considering potential defects before writing test cases could identify additional defects for test cases.