Arguing for Software Quality in an IEC 62304 Compliant Development Process

Safety regulations for medical device software are stipulated in numerous international standards. IEC 62304 addresses software life-cycle processes and identifies core processes, software development activities, and tasks that aim for high-integrity software as a prerequisite for dependability of medical devices controlled by this software. However, these standards prescribe neither a process model nor particular software engineering methods to accomplish the normative requirements. Hence, the manufacturer has to argue in the software development and quality management plans that the selected methods cover the required tasks and are appropriate in order to accomplish high-quality artifacts.

We propose a method for assessing quality- and engineering-centric arguments in dependability cases to assure IEC 62304-compliant software development. Our method is based on an activity-based quality model representing the

impact

of facts about methods and design artifacts on development activities. The impact makes the relation between characteristics of design artifacts and activities contributing to the software safety process explicit. It is derived from state-of-the-art software engineering knowledge and best practices recommended in current safety standards like IEC 61508-3.