Safety-Critical Systems and Agile Development: A Mapping Study

In the last decades, agile methods had a huge impact on how software is developed. In many cases, this has led to significant benefits, such as quality and speed of software deliveries to customers. However, safety-critical systems have widely been dismissed from benefiting from agile methods. Products that include safety critical aspects are therefore faced with a situation in which the development of safety-critical parts can significantly limit the potential speed-up through agile methods, for the full product, but also in the non-safety critical parts. For such products, the ability to develop safety-critical software in an agile way will generate a competitive advantage. In order to enable future research in this important area, we present in this paper a mapping of the current state of practice based on {a mixed method approach}. Starting from a workshop with experts from six large Swedish product development companies we develop a lens for our analysis. We then present a systematic mapping study on safety-critical systems and agile development through this lens in order to map potential benefits, challenges, and solution candidates for guiding future research.Comment: Accepted at Euromicro Conf. on Software Engineering and Advanced Applications 2018, Prague, Czech Republi

Software and systems traceability for safety-critical projects: report from Dagstuhl Seminar 15162

This report documents the program and the outcomes of Dagstuhl Seminar 15162 on “Software and Systems Traceability for Safety-Critical Projects”. The event brought together researchers and industrial practitioners working in the field of safety critical software to explore the needs, challenges, and solutions for Software and Systems Traceability in this domain. The goal was to explore the gap between the traceability prescribed by guidelines and that delivered by manufacturers, and starting from a clean slate, to clearly articulate traceability needs for safety-critical software systems, to identify challenges, explore solutions, and to propose a set of principles and domain-specific exemplars for achieving traceability in safety critical systems

Medical device software as a subsystem of an overall medical device

Embedded software is a sub-system that needs to be integrated with the electrical and mechanical subsystems for a functional medical device to be developed and marketed. In order to be able to develop a medical device system through integrating its sub-systems, the complete system requirements should be known at the start of the project and managed throughout development. Software requirements are then derived from the systems requirements. We have developed and piloted a medical device software process assessment framework called MDevSPICE® that integrates processes from various medical device software standards as well as generic software development standards. This paper describes how the MDevSPICE® framework has been designed so as to enable medical device software developers to produce software that will be safe and easily integrated with other sub-systems of the overall medical device. We also describe the lessons learned from piloting MDevSPICE® in the medical device industry and challenges medical device software developers meet in tracing requirements and risks to and from the system level

How Can Software SMEs Become Medical Device

The amount of software content within medical devices has grown considerably over recent years and will continue to do so as the level of complexity of medical devices increase. This is driven by the fact that software is introduced to produce sophisticated medical devices that would not be possible using only hardware. This therefore presents opportunities for software development SMEs to become medical device software development organisations. However, some obstacles need to be addressed and overcome in order to make the transition from being a generic software development organisation to becoming a medical device software development organisation. This paper describes these obstacles and how research that is currently being performed within the Regulated Software Research Group in Dundalk Institute of Technology may be used to assist with this transitio

Grand Challenges of Traceability: The Next Ten Years

In 2007, the software and systems traceability community met at the first Natural Bridge symposium on the Grand Challenges of Traceability to establish and address research goals for achieving effective, trustworthy, and ubiquitous traceability. Ten years later, in 2017, the community came together to evaluate a decade of progress towards achieving these goals. These proceedings document some of that progress. They include a series of short position papers, representing current work in the community organized across four process axes of traceability practice. The sessions covered topics from Trace Strategizing, Trace Link Creation and Evolution, Trace Link Usage, real-world applications of Traceability, and Traceability Datasets and benchmarks. Two breakout groups focused on the importance of creating and sharing traceability datasets within the research community, and discussed challenges related to the adoption of tracing techniques in industrial practice. Members of the research community are engaged in many active, ongoing, and impactful research projects. Our hope is that ten years from now we will be able to look back at a productive decade of research and claim that we have achieved the overarching Grand Challenge of Traceability, which seeks for traceability to be always present, built into the engineering process, and for it to have "effectively disappeared without a trace". We hope that others will see the potential that traceability has for empowering software and systems engineers to develop higher-quality products at increasing levels of complexity and scale, and that they will join the active community of Software and Systems traceability researchers as we move forward into the next decade of research

Grand Challenges of Traceability: The Next Ten Years

In 2007, the software and systems traceability community met at the first Natural Bridge symposium on the Grand Challenges of Traceability to establish and address research goals for achieving effective, trustworthy, and ubiquitous traceability. Ten years later, in 2017, the community came together to evaluate a decade of progress towards achieving these goals. These proceedings document some of that progress. They include a series of short position papers, representing current work in the community organized across four process axes of traceability practice. The sessions covered topics from Trace Strategizing, Trace Link Creation and Evolution, Trace Link Usage, real-world applications of Traceability, and Traceability Datasets and benchmarks. Two breakout groups focused on the importance of creating and sharing traceability datasets within the research community, and discussed challenges related to the adoption of tracing techniques in industrial practice. Members of the research community are engaged in many active, ongoing, and impactful research projects. Our hope is that ten years from now we will be able to look back at a productive decade of research and claim that we have achieved the overarching Grand Challenge of Traceability, which seeks for traceability to be always present, built into the engineering process, and for it to have "effectively disappeared without a trace". We hope that others will see the potential that traceability has for empowering software and systems engineers to develop higher-quality products at increasing levels of complexity and scale, and that they will join the active community of Software and Systems traceability researchers as we move forward into the next decade of research