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Regulated Software Research Centre

This research is focused upon the development of an international software process improvement (SPI) framework for the medical device industry as a key enabler of best practice for the sector.

The RSRC undertakes a multi-faceted approach to establishing this framework including the examination of best practice from other safety-critical domains, determining how successfully best practice SPI models can be mapped onto regulatory frameworks and, through close liaison with the medical device sector, using empirical studies of industrial practice to inform theory. Therefore, the key research questions, which the RSRC address include:

  1. What software processes are currently being used by medical device software producers?
  2. What lessons can be transferred from software producers in other safety-critical domains operating under different regulatory regimes?
  3. Can best practice software development be used successfully within the medical device sector?
  4. What form should an SPI framework for the medical device sector take?

In addressing these questions, the RSRC adopt a range of quantitative and qualitative research methodologies including experiments, quantitative analysis of data sets, case studies, ethnomethodology, action research and grounded theory to provide a rich analysis of the domain.

The RSRC is undertaking a Lero research project SPRTMDRC which is closely related to this work. Dr Fergal Mc Caffery is the Leader of the Medical Device Software Engineering Competency Group in Lero. The objectives of the SPRTMDRC project includes the automated generation of Software Roadmaps that will be tailored “how to” SPI roadmaps for Irish medical device companies to both improve their software development practices and assist them to achieve regulatory compliance. In addition it will address how to make medical device software development organizations more efficient and also assist them to achieve regulatory compliance by improving how they perform end-to-end traceability of their requirements.

The RSRC is also closely involved with leading worldwide medical device companies and industrial partners. The group is involved in a number of collaborative projects such as the EU FP7 Joint Undertaking Artemis CHARTER project. CHARTER aims to develop concepts, methods, and tools for embedded system design and deployment that will enable developers to master the complexity and substantially improve the development, verification and certification of critical embedded systems.

The RSRC has secured Enterprise Ireland Commercialisation funding for the RESPSENSE project. The aim of this project is to research and develop an innovative hardware and software platform to provide clinical respiratory rate information. This project has attracted keen interest from both clinical and industrial parties alike.

The group can also provide assistance to Irish companies as part of Innovation Voucher scheme run by Enterprise Ireland and Invest Northern Ireland.




Details of the research carried out by the Regulated Software Research Group




Software is becoming an increasingly important aspect of medical devices as it enables highly complex systems to be built. However, medical devices are built within a regulatory environment, and complexity is an enemy of safety.

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