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FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date.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

FMEA is an approach to rooting out and remediating failures. It requires a multi-disciplined team with experts across all departments to succeed. FMEA plans need regular updates to account for changes ...

FMEA (Failure Mode and Effects Analysis) is utilized to identify potential failure modes in the design or manufacturing of a product. But risks associated with medical devices are not created by ...

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.