What is Verification and Validation (V&V)?

Verification and Validation Definition

Verification and validation (V&V) are independent processes that are used together to check that a product, system, or service meets requirements and specifications and that it fulfills its intended use. The European Union Medical Device Regulation (EU MDR) specifies that the results of V&V be part of the technical documentation to demonstrate conformity of the device with respect to general safety and performance requirements. Design V&V are also a part of the FDA’s quality system regulation specified under Title 21 CFR Part 820 and its Design Control Guidance as well as under ISO 13485.

Additional Information

The general types of validation include:

  • Prospective Validation
  • Retrospective Validation
  • Full-Scale Validation
  • Partial Validation
  • Cross-Validation
  • Periodical Validation
  • Concurrent Validation

* Source: https://en.wikipedia.org/wiki/Verification_and_validation


Why is validation and verification important?

Verification and validation play a major role in ensuring that engineering and design teams regularly check that the product is functioning as intended and meets user requirements. These processes also enable teams to document the results of their design work.

*Source: https://www.goddardtech.com

When is it appropriate to use verification versus validation testing?

Verification should be used throughout the design phase to confirm that the product performs according to specifications. Validation testing should occur after the design has been transferred to production to ensure that the product meets its intended use and fulfills user needs.

*Source: https://www.designnews.com

What are the advantages of verification?

Verification reduces the likelihood of design errors occurring in later stages of the new product development process. It also enables product developers to gain greater insight into design improvements that may be needed prior to launch. Lastly, verification ensures that the product design aligns with customer and business requirements at every stage of the development process.

*Source: https://www.browserstack.com

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