--- title: "URRA, Use-Related Risk Analysis | MedTech Terms" description: "Analysis of use scenarios to identify potential use errors and their consequences. Plain-English Quality & Risk definition for MedTech teams, with examples and" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/urra#term", "name": "Use-Related Risk Analysis", "alternateName": "URRA", "description": "A URRA links tasks, potential use errors, and resulting harms - feeding human factors validation testing and ISO 14971 risk control decisions.", "url": "https://medtechterms.com/terms/urra", "termCode": "urra", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/urra#article", "headline": "URRA, Use-Related Risk Analysis", "description": "Analysis of use scenarios to identify potential use errors and their consequences.", "url": "https://medtechterms.com/terms/urra", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/urra" }, "about": { "@id": "https://medtechterms.com/terms/urra#term" }, "articleSection": "Quality & Risk", "inLanguage": "en", "keywords": "Use-Related Risk Analysis, URRA, Quality & Risk, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "FDA Human Factors Guidance", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "FDA - Quality Systems", "url": "https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "ISO 13485 Standard Page", "url": "https://www.iso.org/iso-13485-medical-devices.html", "publisher": { "@type": "Organization", "name": "ISO" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/human-factors#term", "name": "Human Factors Engineering", "alternateName": "HFE", "url": "https://medtechterms.com/terms/human-factors" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iec-62366-1#term", "name": "IEC 62366-1", "url": "https://medtechterms.com/terms/iec-62366-1" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-14971#term", "name": "ISO 14971", "url": "https://medtechterms.com/terms/iso-14971" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Quality & Risk", "item": "https://medtechterms.com/terms?cat=Quality%20%26%20Risk" }, { "@type": "ListItem", "position": 4, "name": "Use-Related Risk Analysis", "item": "https://medtechterms.com/terms/urra" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/urra#faq", "mainEntity": [ { "@type": "Question", "name": "How does a Use-Related Risk Analysis differ from a general risk analysis?", "acceptedAnswer": { "@type": "Answer", "text": "A Use-Related Risk Analysis specifically focuses on risks arising from user interaction with a medical device, identifying potential use errors and their resulting harms. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Use-Related Risk Analysis [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system)URRA # Use-Related Risk Analysis Analysis of use scenarios to identify potential use errors and their consequences. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition A URRA links tasks, potential use errors, and resulting harms - feeding human factors validation testing and [ISO 14971](/terms/iso-14971) risk control decisions. What the regulation says Regulators like the FDA (in their guidance, "Applying Human Factors and Usability Engineering to Medical Devices") and standards such as [IEC 62366-1](/terms/iec-62366-1):2015 ("Medical devices - Part 1: Application of usability engineering to medical devices") expect manufacturers to perform a Use-Related Risk Analysis (URRA) to identify potential use errors and their associated harms. This analysis directly informs the design of the user interface and the planning of human factors validation testing, ensuring that risks related to device use are adequately controlled as part of a comprehensive risk management process defined in [ISO 14971](/terms/iso-14971). ## What this means in practice FDA's human factors guidance expects a documented URRA covering critical tasks, with each tested in summative validation. ## Examples - A URRA for an insulin pump identifies that incorrect programming due to small screen text could lead to under- or over-dosing, informing a design change to increase font size and add confirmation screens. - For a surgical robot, the URRA reveals that a specific control input sequence could be misinterpreted by a surgeon under stress, leading to unintended instrument movement, prompting a revision of the control interface design. - In a diagnostic imaging device, the URRA highlights that a complex workflow for data entry increases the likelihood of patient misidentification, leading to a streamlined user interface to reduce this risk. Common pitfalls - • Failing to link identified use errors directly to potential harms can lead to an incomplete risk assessment. - • Not performing a URRA early enough in the design process can result in costly redesigns and delays. - • Assuming that expert users will not make significant use errors can lead to overlooking critical safety issues. - • Confusing a Use-Related Risk Analysis with a general risk analysis, which broadens the scope beyond user interaction, can lead to inefficiencies. - • Neglecting to update the URRA after design changes or post-market surveillance findings can compromise device safety. ## Frequently asked questions How does a Use-Related Risk Analysis differ from a general risk analysis? A Use-Related Risk Analysis specifically focuses on risks arising from user interaction with a medical device, identifying potential use errors and their resulting harms. A general risk analysis, as outlined in [ISO 14971](/terms/iso-14971), encompasses all potential hazards and hazardous situations related to a medical device's lifecycle, including those not directly linked to user interaction. When should a Use-Related Risk Analysis be conducted? What are the key inputs for a Use-Related Risk Analysis? ## Cross-references ### Used by Things that build on this term. - [ IEC 62366-1 ](/terms/iec-62366-1) ### See also Closely related context worth reading. - [ Use Error ](/terms/use-error) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Human Factors Engineering(HFE) Engineering discipline focused on safe and effective device use by intended users. ](/terms/human-factors)[ Standards IEC 62366-1 Application of usability engineering to medical devices. ](/terms/iec-62366-1)[ 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 FDA· 2 ISO· 1 1. [1 FDA Human Factors Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices) 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 URRA Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=urra) Learn in 60 seconds Card Lesson Quiz Analysis of use scenarios to identify potential use errors and their consequences. - · FDA's human factors guidance expects a documented URRA covering critical tasks, with each tested in summative validation. Remember this Watch out: Failing to link identified use errors directly to potential harms can lead to an incomplete risk assessment. Related terms - [Human Factors Engineering(HFE) ](/terms/human-factors) - [IEC 62366-1 ](/terms/iec-62366-1) - [ISO 14971 ](/terms/iso-14971) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Risk Management File(RMF) ](/terms/risk-management-file) - [Failure Mode and Effects Analysis(FMEA) ](/terms/fmea) - [Hazard, Hazardous Situation, and Harm ](/terms/hazard-vs-harm) - [Summative vs. Formative Evaluation ](/terms/summative-formative) - [Process FMEA vs Design FMEA(PFMEA / DFMEA) ](/terms/pfmea-vs-dfmea) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) [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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