I ran a quick search of Google Scholar for papers which have the terms ‘medical device’ and ‘risk’ in their title. The themes that emerge are shown in the figure below. I wonder if any of these are of interest to ‘A’ who is struggling to focus her research.
Human factors including practitioners’ knowledge of device safety considerations.
The clinical setting includes risk profiling and assurance supported by use of a risk assessment tool such as Medical Device Risk Assessment (MeDRa).
Models and methods include Bayesian network model, FMEA, fault tree analysis and HACCP (Hazard Analysis and Critical Control Points).