Failure Mode and Effects Analysis (FMEA) is a systematic method for identifying and preventing product and process failures. For medical devices, FMEA is required by ISO 14971 for risk management and is critical for FDA and EU MDR compliance.
RPN (Risk Priority Number) = Severity × Occurrence × Detection
Higher RPN values indicate higher priority risks requiring mitigation.
Failure Mode and Effects Analysis for ISO 14971 Risk Management
Risk Priority Number (RPN)
125
High Risk
S × O × D
5 × 5 × 5
Requires attention. Develop mitigation plan within 30 days.
ISO 14971:2019 - Medical Device Risk Management
Requires systematic risk analysis including hazard identification, risk estimation, risk evaluation, and risk control. FMEA is an accepted method for meeting these requirements.
FDA QMSR - Design and Development (ISO 13485 7.3)
FDA's Quality Management System Regulation aligns with ISO 13485:2016, requiring risk analysis as part of design validation per ISO 13485 7.3.6. FMEA documentation supports FDA 510(k) and PMA submissions.
EU MDR Annex I - General Safety Requirements
Requires manufacturers to eliminate or reduce risks through inherent safety by design. FMEA provides evidence of systematic risk assessment.
Best Practices: