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 inadequate for assessing different risks. This study is based on combination of fuzzy linguistic inference model and Failure Mode and Effect Analysis method to evaluate risks in medical device software. The result of traditional FMEA and fuzzy FMEA are compared to show that fuzzy approach is more accurate by involving different expert impacts weights.