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

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