What To Know
Failure Modes and Effects Analysis principles can be applied to design, services, processes or products. DFMEA offers a systematic approach to revealing possible weaknesses in any design, while PFMEA addresses process.
DFMEA (Design FMEA) tests your device design. This failure mode and effects analysis protects against potential medical device design failures from the earliest phase. Design FMEA can significantly streamline product development.
DFMEA systematically identifies every possible design-related cause and failure mode.
The purpose of the DFMEA is to eliminate or reduce medical device design flaws, starting with the highest-priority ones.
How We Can HelpComplex medical device design requirements can create practical challenges. We offer DFMEA/PFMEA experts to help you achieve a compliant, validated medical device for production. I3 Infotek consultants commonly help with:
- Design and perform FMEA and other aspects of risk analysis
- Increase protection against unwanted surprises in production
- Document known risks and associated mitigating actions already in place