--- title: "V&V, Verification & Validation | MedTech Terms" description: "Confirming design outputs meet inputs (V) and that devices meet user needs (V). Plain-English Quality & Risk definition for MedTech teams, with examples and rel" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/verification-validation#term", "name": "Verification & Validation", "alternateName": "V&V", "description": "Verification confirms by examination that specified requirements have been fulfilled (did we build the device right?). 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This iterative approach helps identify and address issues proactively." } }, { "@type": "Question", "name": "Does software V&V have special considerations?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, software V&V, often guided by standards like IEC 62304, requires specific planning and execution to address the unique complexities, risks, and vulnerabilities associated with medical device software, including cybersecurity aspects." } }, { "@type": "Question", "name": "What role do V&V plans, protocols, and reports play?", "acceptedAnswer": { "@type": "Answer", "text": "These documents are essential artifacts that detail the scope, methods, acceptance criteria, and results of all V&V activities, providing objective evidence of compliance for regulatory authorities during submissions and inspections." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Quality & Risk](/terms?cat=Quality%20%26%20Risk) 6. / 7. Verification & Validation [All terms](/terms) Quality & Risk [Quality System](/ecosystems/quality-system)V&V # Verification & Validation Confirming design outputs meet inputs (V) and that devices meet user needs (V). Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Verification confirms by examination that specified requirements have been fulfilled (did we build the device right?). Validation confirms that requirements for a specific [intended use](/terms/intended-use) can be consistently fulfilled (did we build the right device?). What the regulation says Verification and Validation (V&V) are critical aspects of [design controls](/terms/design-controls) for medical devices, as mandated by regulations such as 21 CFR Part 820.30 (Design Controls) by the FDA and Annex I ( [General Safety and Performance Requirements](/terms/gspr)) of the EU [MDR](/terms/mdr-reporting). Regulators expect to see documented evidence that a device meets its specified requirements (verification) and consistently fulfills its [intended use](/terms/intended-use) (validation). [ISO 13485](/terms/iso-13485):2016, clause 7.3.8, emphasizes the need for verification and validation throughout the design and development process. ## What this means in practice V&V plans, protocols, and reports are central artifacts in [design controls](/terms/design-controls) and submissions. Software V&V follows [IEC 62304](/terms/iec-62304). ## Examples - A design team verifies that the output voltage of a power supply in a medical device is within specifications, as defined in the design input requirements. - A clinical study validates that a new diagnostic device accurately identifies a specific disease in a patient population, fulfilling its intended use. - Software verification involves unit testing individual modules to ensure they function according to their software requirements specifications. Common pitfalls - • A common pitfall is conflating verification and validation activities, leading to incomplete testing or a failure to address user needs effectively. - • Another mistake is performing V&V too late in the design process, making it costly and difficult to implement necessary changes. - • Failure to adequately document V&V activities can result in regulatory non-compliance during audits or submissions. - • Not considering cybersecurity V&V throughout the product lifecycle can lead to vulnerabilities in connected MedTech devices. - • Over-reliance on software simulations without sufficient hardware testing for embedded systems is a frequent pitfall in software V&V. ## Frequently asked questions What is the primary difference between verification and validation? Verification confirms that design outputs meet design inputs, essentially ensuring the device was built correctly according to specifications. Validation confirms that the device meets user needs and its [intended use](/terms/intended-use), ensuring the correct device was built for its purpose. When should verification and validation activities occur? Does software V&V have special considerations? What role do V&V plans, protocols, and reports play? ## Cross-references ### Part of A larger framework or document this term belongs to. - [ Design Controls ](/terms/design-controls) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Design Controls Structured process governing the design of medical devices. ](/terms/design-controls)[ Standards IEC 62304 Lifecycle requirements for medical device software. ](/terms/iec-62304) ### QMS Foundations · From this learning path [ Quality & Risk Design History File(DHF) Compilation of records describing the design history of a finished device. Adjacent lesson ](/terms/design-history-file?from=qms-foundations)[ Quality & Risk Complaint Handling Process for receiving, evaluating, and responding to device complaints. ](/terms/complaint-handling?from=qms-foundations)[ Quality & Risk Corrective and Preventive Action(CAPA) Systematic process to investigate and resolve quality issues and prevent recurrence. ](/terms/capa?from=qms-foundations)[ Quality & Risk FDA Form 483 Notice of inspectional observations issued at the conclusion of an FDA inspection. ](/terms/form-483?from=qms-foundations) ### Software Team Onboarding · From this learning path [ Software & AI Clinical Decision Support(CDS) Software providing healthcare professionals with knowledge and patient-specific information. Adjacent lesson ](/terms/cds?from=software-team-onboarding)[ Software & AI Software of Unknown Provenance(SOUP) Software not developed for medical device use, or lacking adequate development records, incorporated into a device. Adjacent lesson ](/terms/soup?from=software-team-onboarding)[ Software & AI Predetermined Change Control Plan(PCCP) FDA mechanism to pre-authorize specific modifications to AI/ML-enabled devices. ](/terms/ai-ml-pccp?from=software-team-onboarding)[ Cybersecurity Section 524B of the FD&C Act(524B) The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices. ](/terms/section-524b?from=software-team-onboarding) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [QMS Foundations](/paths/qms-foundations)Lesson 5 of 10 - [Software Team Onboarding](/paths/software-team-onboarding)Lesson 6 of 12 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 V&V Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=verification-validation) Learn in 60 seconds Card Lesson Quiz Confirming design outputs meet inputs (V) and that devices meet user needs (V). - · V&V plans, protocols, and reports are central artifacts in design controls and submissions. - · Software V&V follows IEC 62304. - · Validation confirms that requirements for a specific intended use can be consistently fulfilled (did we build the right device?). Remember this Watch out: A common pitfall is conflating verification and validation activities, leading to incomplete testing or a failure to address user needs effectively. Related terms - [Design Controls ](/terms/design-controls) - [IEC 62304 ](/terms/iec-62304) You may also need Auto-suggested from Quality & Risk and shared keywords. - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [Nonconformance (NCR)(NCR) ](/terms/nonconformance) - [Summative vs. Formative Evaluation ](/terms/summative-formative) - [ISO 13485 ](/terms/iso-13485) - [AI Act Transparency Obligations ](/terms/ai-act-transparency-obligations) - [CAPA Effectiveness Check ](/terms/capa-effectiveness) [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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