A Systematic Approach to Quality Requirement Management in Medical Software.

BACKGROUND The quality requirements for medical software have become increasingly demanding. Several quality standards and models are already in place, but there is a debate on whether these are specific enough for medical software. Moreover, mapping requirements to quality criteria can be challenging but is required throughout the software development process. OBJECTIVES We propose a workflow in which we apply proven methods and tools for systematic collection, analysis, and evaluation of software quality criteria based on the ISO/IEC 25010:2011. METHODS We employ affinity diagrams, Kano analysis and quality function deployment for the systematic requirement development, analysis, and management. RESULTS We outline a systematic approach on how to use the recommended process when developing medical software. CONCLUSION The paper proposes a systematic approach for requirements management that could be used for mapping medical software quality criteria and stakeholder requirements, independent from the quality criteria (and the underlying model) itself.