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.
