IVD Glossary Terms (U-Z)

Validation
Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. Please see also: verification....
Verification
Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. Please see also: validation....
Warnings
Information to make users aware of potential serious adverse events or safety hazards that may occur if device is used improperly....

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