Glossary
Selected key terms pertaining to medical device development are listed below with References.
Key Terms
There are currently 5 key terms in this directory beginning with the letter V.
validation
confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled
[FDA 21CFR820]
validation
confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled
[ISO 9000:2015]
verification
confirmation, through the provision of objective evidence, that specified requirements have been fulfilled
Note 1: The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.
Note 2: The activities carried out for verification are sometimes called a qualification process.
Note 3: The word “verified” is used to designate the corresponding status.
Note 1: The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents.
Note 2: The activities carried out for verification are sometimes called a qualification process.
Note 3: The word “verified” is used to designate the corresponding status.
[ISO 9000:2015, ISO 14971:2019]
verification
confirmation by examination and provision of objective evidence that specified requirements have been fulfilled
[FDA 21CFR820, ISO 20916:2019]
Medical device developers are strongly encouraged to consult the listed reference for each key term to fully understand the context behind the definition and its intended application.
Definitions from the FDA Code of Federal Regulation (CFR) are listed without dates and are accurate through December 2020. Consult the listed FDA reference (online) to confirm the latest definition.