A Framework for Taxonomy Based Testing Using Classification of Defects in Health Software-SW91

Abstract

Taxonomy based testing is an efficient approach to find software defects at earlier phases of medical device software development. It allows the creation of goal oriented test cases while brainstorming test ideas. This approach is adaptable into standard testing processes such as the ISTQB and the 29119-2. It uses a new standard, a defect taxonomy SW91 which is identified as a consensus standard by the US Food and Drug Administration (FDA). This paper presents steps to be followed in implementing taxonomy based testing at a medical device software organisation which follows the software development process explained in IEC 62304:2006+A1:2015. Finally, the future work section explains how this framework can be tailored to testing techniques and how its efficiency and benefits will be evaluated via expert reviews and implementation at medical device software organisations.