Medical Devices 2011 - Failure Mode and Effects Analysis for Design Improvement and Design Control

In this Failure Mode and Effects Analysis training, learn how you can design medical devices that enhance reliability, durability, safety, and serviceability. Get a solid understanding of both the Design FMEA, and the Process FMEA.

Risk analysis is now required by law (GMP). Identification of device design problems prior to distribution eliminates costs associated with warranties, product recalls, and product validation.

FMEA can reveal missing requirements, missing functions, and point out component and manufacturing problems well before process validation. These in turn reduce life cycle costs and reduce the time to market. Design FMEA serves as a central document in the Design Control process Similarly the Process FMEA serves as the central document in the Process Validation qualification.