SPRTMDRC

Software Processes and Roadmaps for Medical Device Regulatory Compliance

Background and justification for work programme

Software is becoming an increasingly important aspect of a Medical Device (MD) as it enables highly complex systems to be built. However, MDs are built within a regulatory environment, and complexity is an enemy of safety. Therefore, documented processes are important for adherence to MD regulatory requirements. MDs can only be marketed if compliance with and guidance from appropriate regulatory bodies is achieved.

The main area of concern, particularly for small MD companies in relation to their software development practices is to ensure that the elements required by the regulatory bodies are in place rather than trying to improve their overall software development practices. This work programme will deliver processes, roadmaps and traceability assistance for organisations developing medical devices software. To perform this research, the research team will be involved in 2 related tasks.

Task 1 - Automated Generation of Software Process Roadmaps

This research will provide tailored “how to” SPI roadmaps for Irish MD companies to both improve their software development practices and assist them to achieve regulatory compliance. The roadmaps produced will provide step-by-step instructions as to how each particular practice that is specified to the Process Reference Models may be fulfilled. This will be achieved though assessing a MD company’s current process, the requirements of their product, and the regulatory guidelines for that process. The output will be process roadmaps specifically tailored to company requirements. A repository of step-by-step process roadmaps will be compiled using software product lines techniques for categorizing and versioning. This will enable medical device organizations to obtain a roadmap for improvement that is specifically tailored to meet their requirements.

Task 2 - Traceability within Medical Device Software Development Environments

Traceability is critical to medical device software development. Within this task we improve medical device software development traceability, particularly for SMEs. This task aims to make MD 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.