Problems and defects are expensive. Customers understandably place high expectations on manufacturers and service providers ...

Purpose: Failure mode and effects analysis (FMEA) was used to evaluate a smart i.v. pump as it was implemented into a redesigned medication-use process. Summary: A multidisciplinary team conducted a ...

FMEA is a process for analysis of potential failure modes within a design, process, or product, classified by severity or determination of the effect of failures on the system. Widely used in ...

If you are still using FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date. And you might be asking why do you need to ...