Validation and verification (medical devices)

Validation and verification are procedures that ensure that medical devices fulfil their intended purpose.

Validation or verification is generally needed when a health facility acquires a new device to perform medical tests.

The main difference between the two is that validation is focused on ensuring that the device meets the needs and requirements of its intended users and the intended use environment, whereas verification is focused on ensuring that the device meets its specified design requirements.

For instance, a regulatory agency (such as CE or FDA) may ensure that a product has been validated for general use before approval.

The results should be evenly spread throughout the published reference range rather than clustered at one end.