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    Quality & RiskQuality SystemV&V

    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

    A larger framework or document this term belongs to.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    MDIC·1FDA·1ISO·1
    1. 1
      MDIC Case for Quality
      Verified
      MDICmdic.org
    2. 2
      FDA - Quality Systems
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.