Phasing Out Asymptotically
Design transfer occurs most smoothly when it is an integral part of the project plan. Throughout the design phase, we actively maintain our design documentation through an ISO-certified program.
At the end of the project, you will receive all the documents you need, such as the Design History File, Performance Test Reports, and Fabrication Drawings. For a medical device, our documentation package includes all of the design documentation you need to prepare an FDA 510k or PMA application. We will also support the production team so ramp-up goes as smoothly as possible.