Research project AHMED aims to create an approach to regulatory requirements that takes into account processes, practices and tools of continuous software engineering. This includes identification of best recognized patterns and practices in agile medical device development following continuous software practices as well as tools and techniques that can provide support for traceability, risk management, and verification and validation. The research covers both software engineering perspective and data science, ML and AI. As concrete demonstrators, we work with partner companies on case studies that reflect partners’ business needs.
In the technical implementation of the project, the focus is placed on selecting the best techniques, tool suggestions and their integration and support for risk management, traceability, and validation and verification. To validate these, we plan to run lightweight experiments by participating companies to test the approach with their services.