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 ...

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

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 ...

A Failure Mode and Effects Analysis (FMEA) is a “bottom-up” type of system analysis that is required for the standards certification of functional safety: IEC 61508 and all the standards deriving from ...

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FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date.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 ...

FMEA is a flexible methodology for addressing potential failure points and implementing lasting changes. Common mistakes are a normal occurrence in FMEA but are easily addressed. Proper implementation ...

This paper describes the methodology employed during the development of a System on Chip (SoC) platform developed for automotive applications. The methodology is based on the following major aspects.