All terms
Verification & Validation
Confirming design outputs meet inputs (V) and that devices meet user needs (V).
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast 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 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 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) of the EU MDR. Regulators expect to see documented evidence that a device meets its specified requirements (verification) and consistently fulfills its intended use (validation). 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 and submissions. Software V&V follows 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
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, ensuring the correct device was built for its purpose.
Cross-references
Part of
Related terms
Shared paths + categoryQuality & Risk
Design Controls
Structured process governing the design of medical devices.
QMS Foundations · adjacent
Standards
IEC 62304
Lifecycle requirements for medical device software.
Software Team Onboarding
Quality & Risk
Design History File(DHF)
Compilation of records describing the design history of a finished device.
QMS Foundations · adjacent
Software & AI
Clinical Decision Support(CDS)
Software providing healthcare professionals with knowledge and patient-specific information.
Software Team Onboarding · adjacent
Quality & Risk
Complaint Handling
Process for receiving, evaluating, and responding to device complaints.
QMS Foundations
Quality & Risk
Corrective and Preventive Action(CAPA)
Systematic process to investigate and resolve quality issues and prevent recurrence.
QMS Foundations
Latest in MedTech
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
MDIC·1FDA·1ISO·1
- 1MDIC Case for QualityVerifiedMDICmdic.org
- 2FDA - Quality SystemsVerifiedFDAfda.gov
- 3ISO 13485 Standard PageVerifiedISOiso.org
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