Medical device software risk assessment using FMEA and fuzzy linguistic approach: Case study


In medical device software domain, risk management is a crucial process. With complex systems, medical device software safety becomes more complicated to achieve. Traditional Failure Mode Effect and Analysis (FMEA) have been used for medical device software development for a while. However, there are many studies reveal that traditional approach is… (More)
DOI: 10.1109/SACI.2016.7507369


11 Figures and Tables