--- title: "FMEA, Failure Mode and Effects Analysis | MedTech Terms" description: "Bottom-up technique for systematically identifying potential failures and their effects. Plain-English Quality & Risk definition for MedTech teams, with example" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/fmea#term", "name": "Failure Mode and Effects Analysis", "alternateName": "FMEA", "description": "FMEA evaluates each component or process step to identify failure modes, their causes, effects, and severity, occurrence, and detectability ratings used to prioritize mitigation. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Failure Mode and Effects Analysis [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system)FMEA # Failure Mode and Effects Analysis Bottom-up technique for systematically identifying potential failures and their effects. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition FMEA evaluates each component or process [step](/terms/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). What the regulation says Failure Mode and Effects Analysis (FMEA) is a systematic approach recognized by regulatory bodies for identifying potential failure modes in products and processes. While not a standalone requirement, it contributes significantly to risk management activities mandated by standards like [ISO 14971](/terms/iso-14971), which outlines a comprehensive approach to medical device risk management. The FDA, for instance, expects manufacturers to establish and maintain procedures to identify hazards and estimate risks, where FMEA can serve as a valuable tool. ## What this means in practice FMEA is a useful input to [ISO 14971](/terms/iso-14971) risk management but is not, by itself, sufficient - ISO 14971 requires a top-down hazard analysis as well. ## Examples - A design FMEA (dFMEA) is conducted on a new infusion pump to identify potential mechanical or software failures that could lead to incorrect drug delivery. - A process FMEA (pFMEA) is performed on the sterilization process for a surgical instrument to identify potential steps that could lead to incomplete sterilization. - A use FMEA (uFMEA) is applied to a home-use diagnostic device to identify potential user errors or interactions that could lead to inaccurate results or patient harm. 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. ## Frequently asked questions What is the primary output of an FMEA? The primary output of an FMEA is a prioritized list of potential failure modes, along with their causes, effects, and risk priority numbers (RPN) or equivalent scores, indicating which risks require mitigation. How does FMEA relate to ISO 14971? Can FMEA be used for cybersecurity risk management? ## Cross-references ### Used by Things that build on this term. - [ ISO 14971 ](/terms/iso-14971) ### Often confused with Distinct concept frequently mistaken for this one. - [ Fault Tree Analysis(FTA) FMEA is bottom-up; FTA is top-down. ](/terms/fta) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Fault Tree Analysis(FTA) Top-down deductive analysis tracing how faults can combine to cause an undesired event. ](/terms/fta)[ Quality & Risk Hazard, Hazardous Situation, and Harm ISO 14971 distinction underpinning all medical-device risk analysis. ](/terms/hazard-vs-harm)[ Standards ISO 14971 International standard for the application of risk management to medical devices. ](/terms/iso-14971) ### More in Quality & Risk · Same category [ Quality & Risk Biocompatibility Ability of a material to perform with an appropriate host response in a specific application. ](/terms/biocompatibility)[ Quality & Risk CAPA Effectiveness Check Verification step confirming a corrective or preventive action actually fixed the problem. ](/terms/capa-effectiveness)[ Quality & Risk Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. ](/terms/change-control)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 MDIC· 1 FDA· 1 ISO· 1 1. [1 MDIC Case for Quality Verified MDIC · mdic.org ](https://mdic.org/program/case-for-quality/) 2. [2 FDA - Quality Systems Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices) 3. [3 ISO 13485 Standard Page Verified ISO · iso.org ](https://www.iso.org/iso-13485-medical-devices.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Tying cybersecurity into your QMS? We help align cybersecurity activities with ISO 13485 design controls and ISO 14971 risk management. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Quality & Risk Acronym FMEA Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=fmea) Learn in 60 seconds Card Lesson Quiz Bottom-up technique for systematically identifying potential failures and their effects. - · 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. - · Variants include design FMEA (dFMEA), process FMEA (pFMEA), and use FMEA (uFMEA). Remember this Watch out: 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. Related terms - [ISO 14971 ](/terms/iso-14971) - [Fault Tree Analysis(FTA) ](/terms/fta) - [Hazard, Hazardous Situation, and Harm ](/terms/hazard-vs-harm) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Process FMEA vs Design FMEA(PFMEA / DFMEA) ](/terms/pfmea-vs-dfmea) - [Corrective and Preventive Action(CAPA) ](/terms/capa) - [Use-Related Risk Analysis(URRA) ](/terms/urra) - [Change Control ](/terms/change-control) - [Design Controls ](/terms/design-controls) - [Risk Management File(RMF) ](/terms/risk-management-file) [All Quality & Risk terms](/terms?cat=Quality%20%26%20Risk) From the Blue Goat network Related resources and services on this topic. - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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