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FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date.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

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 (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 article provides insights into the importance of an IC’s pin failure mode and effects analysis (FMEA) to comply with ...

FMEA is a structured approach used to identify ways in which a product or process can fail, estimate risk associated with specific causes, and prioritize actions that should be taken to reduce risk.