Verification and Validation (VAV)

Verification and validation are two important activities in the FDA's Software as a Medical Device (SaMD) risk management framework. Verification is the process of evaluating the software design to ensure that it meets the specified requirements, while validation is the process of evaluating the software to ensure that it meets the intended use and user needs.

Controls related to this risk category are listed as below:

• VAV 01 - TEVV Documentation

• VAV 02 - Tools for TEVV

• VAV 03 - Evaluations of Human Subjects