Failure modes and effects analysis can be a helpful tool in risk management for medical devices, but it has several inherent traps that should be recognized and avoided.

In recent years, the subset of Failure Mode and Effects Analysis (FMEA) has become a valuable tool in corporate settings, helping engineers spot potential risks in product design before significant ...

Google “FMEA” and you’re likely to find a variety of definitions. Risk assessment tool. Process methodology. Predictive failure analysis. It’s used as a noun, a verb and an adjective. So, what is it ...

This article provides insights into the importance of an IC’s pin failure mode and effects analysis (FMEA) to comply with functional-safety standards such as IEC 61508 and ISO... 1. FMEA and its ...