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FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date.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 one of the most powerful approaches to safeguarding your projects from failures and defects. It isn’t a cakewalk to implement, but in the right hands, it can make projects run without a hitch.

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 ...

Effective occupational health and safety management requires a structured approach to hazard identification and risk assessment, which is best achieved by a management system. The implementation of an ...

Participants will learn the purpose and benefits of FMEA, the different types of FMEAs and their focus, QS-9000 FMEA requirements and guidelines, FMEA timing and inputs, and steps required for ...

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 application note provides a Failure Modes and Effects Analysis (FMEA) for the device pins of NXP Semiconductors logic controlled high side NX3P series power switches. The NX3P high-side load ...