The focus of the work has been on what is often called “smart devices” or “digital devices with limited functionality”, with a particular emphasis on their software, and it does not discuss in detail aspects of the justification common to analogue devices, e.g., environmental qualification and type testing.
From our review, we have extracted and analysed several common themes, including the role of certification in the overall justification and whether certification on its own might be enough, and market factors that might influence the approach and deployment of commercial digital components.
