Failure Mode and Effects Analysis (FMEA) is one of the most used methodologies for quality and reliability and is an effective tool for assessing fault failures, root cause analysis, and failure modes. FMEA is a highly valuable tool to guide the process of development and is required by various industry standards and regulations. An important quality assurance function is assessing risk for the critical characteristics of a medical device, throughout its life cycle. This is true for any medical device where compliance is required with either the US FDA, EU, or the ISO-14791 quality standard. FMEA provides a way to assess points of failure in a specific design, ...