Failure Modes and Effects Analysis (FMEA)

Failure Modes and Effects Analysis (FMEA) is a proactive risk assessment tool used in various industries, including the medical device industry. FMEA is a systematic approach to identifying and preventing potential failures or problems before they occur. It involves identifying potential failure modes (ways in which a process or product can fail) and their potential effects, analyzing the severity of the consequences, the likelihood of the occurrence, and the ability to detect the failure. The goal of FMEA is to reduce the risk of failure and improve product and process reliability and safety. FMEA can be applied at different stages of the product lifecycle, including design, development, manufacturing, and post-market surveillance.