Abstract: Emerging medical devices are highly relying on embedded software that runs on the specific platform in real time. The development of embedded software is different from ordinary software development due to the hardware-software dependency. MDevSPICE® has been developed to provide guidance to support such development. To increase the flexibility of this framework agile practices have been introduced. This paper outlines the challenges for embedded medical device software development and the structure of MDevSPICE® and suggests a suitable combination of agile practices that will help to add flexibility and address corresponding challenges of embedded medical device software development.
Abstract: The importance of good requirements engineering is well documented. Agile practices, promoting collaboration and communications, facilitate the elicitation and management of volatile requirements. However, current Agile practices work in a well-defined environment. It is necessary to have a co-located customer. With distributed development it is not always possible to realize this co-location. In this environment a suitable process, possibly supported by tools, is required to support changing requirements. This paper introduces the issues of concern when managing requirements in a distributed environment and describes work done at the Software Technology Research Centre as part of the NOMAD project.