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FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date.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

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

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 ...

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 ...

This course presents an overview of the Failure Mode and Effects Analysis (FMEA) approach to calculate risk and proactively avoid potential failures in a process or service. Participants learn about ...