FMEA evaluates each component or process step to identify failure modes, their causes, effects, and severity, occurrence, and detectability ratings used to prioritize mitigation. Variants include design FMEA (dFMEA), process FMEA (pFMEA), and use FMEA (uFMEA). Each failure mode is commonly scored for severity, occurrence and detection, sometimes multiplied into a risk priority number (RPN), although many MedTech teams prefer action priority tables because RPNs can hide high severity risks. In medical devices, FMEA supports ISO 14971 risk analysis but does not replace it: FMEA is bottom-up and single-fault, so it can miss hazards that arise from normal use or combined faults.

Why it matters

FMEA is a useful input to ISO 14971 risk management but is not, by itself, sufficient - ISO 14971 requires a top-down hazard analysis as well.

Common pitfalls

•FMEA alone is not sufficient to meet the requirements of a comprehensive risk management system like that described in ISO 14971, which also requires a top-down hazard analysis.
•Focusing solely on FMEA without considering the broader context of system-level hazards can lead to an incomplete risk profile.
•Incorrectly assigning severity, occurrence, or detectability ratings can result in an inaccurate prioritization of risks.
•FMEA can be perceived as a one-time exercise rather than an iterative process that evolves throughout the device lifecycle.
•Failing to link FMEA outputs directly to risk control measures and verification activities can diminish its effectiveness.

Sources

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.