The popularity of Agile software development is growing rapidly with an increasing number of projects being developed following Agile methodologies such as Scrum and XP [1]. Research has revealed that following Agile practices when developing software can have a significantly positive impact in reducing development time, reducing cost and increasing overall quality [2-4]. Whilst Agile practices can have a positive impact on a development project there are incompatibilities between Agile methodologies and the plan driven approaches followed when developing safety critical software [5, 6]. However, it has been recognised that “formal techniques may be used in an agile way” [5]. Case studies have been performed in organisations developing safety critical software which validate this statement [7-9]. This Ph.D. is focusing on the area of medical device software development and integrating Agile software development principles into traditional plan driven lifecycles for use in developing medical device software
