Page 260 - Safety Risk Management for Medical Devices

APPENDIX B: TEMPLATES

In the following pages certain templates are provided as an aid to risk management
practitioners.
Design Failure Modes and Effects Analysis (DFMEA) template
Software Failure Modes and Effects Analysis (SFMEA) template
Process Failure Modes and Effects Analysis (PFMEA) template
Use-Misuse Failure Modes and Effects Analysis (UMFMEA) template
Risk Assessment and Control Table (RACT) template

239