Design Verification

The design control regulation requires that "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, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF."

Design verification seeks to establish that a product performs as intended. This is most commonly understood as the process of testing the product with respect to its specifications. Design verification, however, is more than just testing. It also includes all inspection and analyses that are performed to demonstrate that specifications are met. Thus, incoming inspection of parts is, in many instances, also part of the design verification record. All traceability analyses performed to ensure that all requirements have corresponding specifications are considered to be design verification record as well.

AlvaMed consultants can assist in documenting your design verification activities by preparing verification protocols and procedures and the resulting reports.
 

We invite you to review a case study that is representative of the work done by our consultants...
 

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