We will produce verification prototypes using released procedures, manufacturing processes representative of the commercial production process, and full material traceability. The devices may be built using final procedures and tooling, but this depends on the device’s complexity and the production volumes necessary. In some cases, devices may need to be assembled manually with fixtures representative of automated machinery, in which case assembly processes are validated. Verification prototypes may be packaged and sterilized to test the devices under realistic conditions.

We will perform verification testing on devices representing the final product with fully documented processes and material traceability. We will perform verification testing using the final verification protocols and provide accelerated ageing and environmental conditioning testing if necessary.  Verification testing will be performed by the Design by Boyd team or with external testing laboratories. 

During the Verification & Validation phase, we will produce validation prototypes using fully validated processes. The validation devices will be packaged, sterilized, and conditioned. 

Validation testing will be performed with devices produced using production processes, and testing will be performed by qualified clinical personnel to released protocols.

At the end of the Verification & Validation phase, a final design review will be held to verify that all design requirements have been met, all risk management items have been closed, and all tasks in the development plan, risk plan, verification plan, and validation plan have been completed. The team at Design by Boyd will complete the device master record (DMR) and device history record (DHR).