--- title: "FTA, Fault Tree Analysis | MedTech Terms" description: "Top-down deductive analysis tracing how faults can combine to cause an undesired event. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Fault Tree Analysis [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system)FTA # Fault Tree Analysis Top-down deductive analysis tracing how faults can combine to cause an undesired event. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition FTA per IEC 61025 uses Boolean logic to model how component-level faults and external events combine to cause a defined top-level hazardous event, supporting both qualitative and quantitative analysis. What the regulation says Fault Tree Analysis (FTA) is recognized by regulatory bodies as a systematic risk analysis technique. For instance, the FDA emphasizes comprehensive risk management per 21 CFR Part 820, [Quality System Regulation](/terms/qsr), which can include FTA. Under the EU [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745) Annex I, [General Safety and Performance Requirements](/terms/gspr), manufacturers are required to establish, implement, document, and maintain a risk management system, for which FTA can be a valuable tool. ## What this means in practice Often paired with [FMEA](/terms/fmea): FTA reasons backward from a harm; FMEA reasons forward from components. FTA is favored for systems with safety-critical software and rare catastrophic failure modes. ## Examples - A medical device manufacturer uses FTA to analyze how a combination of software bugs, sensor malfunctions, and user errors could lead to an incorrect drug dosage delivery by an infusion pump. - A team developing an AI-powered diagnostic tool employs FTA to map out how various system component failures and data integrity issues could result in a misdiagnosis, identifying critical control points. - A cybersecurity team utilizes FTA to determine the pathways by which a denial-of-service attack could successfully incapacitate a networked hospital imaging system, informing their mitigation strategies. Common pitfalls - • Failing to clearly define the top-level event can lead to a convoluted and ineffective fault tree. - • Overlooking common cause failures or human error in the fault tree can significantly underestimate risk. - • Treating FTA as a standalone activity rather than an iterative part of the product lifecycle reduces its effectiveness. - • Applying FTA to systems without well-defined failure modes or clear causal relationships can yield misleading results. - • Not adequately validating the fault tree against real-world data or expert opinion can compromise its accuracy and credibility. ## Frequently asked questions How does FTA support compliance with risk management standards? FTA provides a structured, top-down approach to identify root causes of system failures, directly supporting the requirements of [ISO 14971](/terms/iso-14971):2019 for risk analysis by helping to identify hazards and hazardous situations. Can FTA be used for cybersecurity risk assessment? What is the primary benefit of FTA over other risk analysis methods? ## 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. - [ Failure Mode and Effects Analysis(FMEA) FMEA is bottom-up; FTA is top-down. ](/terms/fmea) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Failure Mode and Effects Analysis(FMEA) Bottom-up technique for systematically identifying potential failures and their effects. ](/terms/fmea)[ 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 IEC· 1 MDIC· 1 FDA· 1 1. [1 IEC 61025 Verified IEC · webstore.iec.ch ](https://webstore.iec.ch/publication/4311) 2. [2 MDIC Case for Quality Verified MDIC · mdic.org ](https://mdic.org/program/case-for-quality/) 3. [3 FDA - Quality Systems Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices) 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 FTA Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=fta) Learn in 60 seconds Card Lesson Quiz Top-down deductive analysis tracing how faults can combine to cause an undesired event. - · Often paired with FMEA: FTA reasons backward from a harm; FMEA reasons forward from components. - · FTA is favored for systems with safety-critical software and rare catastrophic failure modes. Remember this Watch out: Failing to clearly define the top-level event can lead to a convoluted and ineffective fault tree. Related terms - [Failure Mode and Effects Analysis(FMEA) ](/terms/fmea) - [ISO 14971 ](/terms/iso-14971) You may also need Auto-suggested from Quality & Risk and shared keywords. - [CAPA Effectiveness Check ](/terms/capa-effectiveness) - [Hazard, Hazardous Situation, and Harm ](/terms/hazard-vs-harm) - [Servicing (21 CFR 820.200) ](/terms/servicing) - [Use Specification ](/terms/use-specification) - [Budget Impact Model(BIM) ](/terms/budget-impact-model) - [Corrective and Preventive Action(CAPA) ](/terms/capa) [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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