Design Verification

Testing to ensure that all design outputs meet design input requirements. Design verification may include activities such as:

• Design Review
• Performing Alternate Calculations
• Understanding Tests and Demonstrations
• Review of Design Stage Documents Before Release

Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, methods, date, and the individuals performing the verification, shall be documented in the Design History File.

Design verification is the process by which design outputs are compared to design input requirements to determine whether they have been met. Design verification may take a number of different forms. Risk analysis is often considered to be part of design verification and will commonly take the form of a Failure Mode and Effects Analysis. Bench-top tests and quality inspections are also common forms of verification and may serve as mitigating actions as part of the Failure Mode and Effects Analysis. A design matrix (a table in which the design inputs are matched with the design outputs) is another tool used in design verification.

Design verification precedes design validation and is not a substitute. The two are distinctly different and should be treated as such. The Quality System Regulation defines design verification as confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.