Stage 5: Transfer
Once the CE mark was obtained, the actual delivery of the product started. Our main role was to monitor the production of the first batches. We checked whether the quality procedures as developed in the previous phase were indeed effective and all trace ability data was stored properly. Because when more surgeons started using the implant it was unavoidable that some issues appeared during use. During this project we had to solve issues with the screw driver and reduction instrument. In that phase we addressed those issues and solved them appropriately. Although the product is already CE marked we decided to conduct, together with a team of surgeons, a post market clinical follow up study in order to address the residual risk topics.
Once the production batches run smoothly the customer took over the CE mark by means of an own brand labeling contract.Both cage as screw system are on the market for a couple of years now. For specific information, don’t hesitate to contact us: 0031-88-5656600 or mail us at email@example.com.