Process validation

The fundament is based on system understanding, multivariate analysis, confidences and reliability and definitions of outcomes.

The validation for medical devices are guided by GHTF/SG3/N99-10:2004 (Edition 2).

By the use of a design validation protocol, it is possible to determine if the item will deliver its full functionality based on the URS. It should also conform to the requirements of the Validation Master Plan.