Software process improvement and roadmapping - a roadmap for implementing IEC 62304 in organizations developing and maintaining medical device software

Abstract

Organizations engaged in medical device software are required to demonstrate compliance with a set of medical device standards and regulations before the device can be marketed. One such standard IEC 62304, Medical device software - Software life cycle processes, is a standard that defines the processes that are required to be executed in order to develop safe software. Demonstrating compliance with IEC 62304 can be problematic for organizations that are new to or have limited experience in the domain. The standard defines what processes must be carried out, but does not state how. This paper presents a research method for generating a roadmap that will guide organizations in the implementation of IEC 62304.