HOW CAN QUALITY REQUIREMENTS FOR MEDICAL SOFTWARE BE SYSTEMATICALLY FULFILLED BETTER?

Abstract

Due to a variety of factors, among others medical and legislative requirements, the quality requirements on medical software become increasingly demanding. Several quality standards and guidelines are already in place, e.g., ISO/IEC s9126, 14598 and 25000 (SQaRE). However, there is a debate on whether these standards are not specific enough for medical software. Furthermore, their effective application for requirement gathering, analysis and monitoring can be difficult. In this paper, we propose a workflow for the application of the ISO/IEC 25010:2011 standard for the systematic collection, analysis and evaluation of requirements for various stakeholders in order to systematically better fulfill quality requirements on medical software