The significance of requirements in medical device software development

Software to be used in or as a medical device is subject to user requirements. However, unlike unregulated software, medical device software must meet both the user’s requirements and the requirements of the regulatory body of the region into which the software will be marketed. Regulatory requirements are fixed and can be planned for; unfortunately, the same is not true with user requirements. As many medical device software development organisations are following traditional sequential Software Development Life Cycles (SDLC), they are experiencing difficulties accommodating changes in requirements once development has begun. Agile methods and practices offer the ability to overcome the challenges associated with following a sequential SDLC. Whilst the regulatory requirements are fixed, this paper presents these requirements and shows how they appear to mandate the use of a sequential SDLC. This paper also explains how agile methods and practices can be successfully adopted in the development of medical device software without hindering the process of achieving regulatory approval.