This training manual shows how to use failure mode and effects analysis (FMEA) in the manufacture of medical devices and looks at regulatory requirements related to manufacturing of medical devices, risk management, and other risk analysis methodologies. Chapters cover FMEA procedures and the FMEA team, common tools used with FMEA, design, process, application, and service FMEA, post-FMEA study, and control plans. A final chapter offers an overview of failure mode, effects, and criticality analysis (FMECA). There is no subject index.