Adaptation of the Technical Documentation

"The devil is in the details"

Our client was in the process of recertifying his main product and approached us due to the lack of resources required to update the relevant parts of his Technical Documentation.

Therefore, our task was to find update experts within our team as quickly as possible, who are familiar with the product and are up-to-date in terms of regulations.

During the implementation of the project, the contact person repeatedly urged our team of experts to keep the level of detail in the documentation manageable. Our experts know the fine line between "too much detail talked out" and "the Notified Body constantly asks for more details" and always find the right balance.

With our team of experts, the depth of detail was optimized and important details were no longer left out. There were certainly discussions between the client and the expert team regarding the level of detail, but they were always able to agree.

During the subsequent submission of the Technical Documentation, the reviewer however focused on exactly these points, which repeatedly led to discussions during the project due to the supposed attention to detail. Without the level of detail brought in by our qtec team of experts, the customer would not have passed the recertification. After completion of the documentation, the client was happy that our team, due to their knowledge and expertise, was able to assert itself in the right places - and thus lead the project to success.

Projekt Key Figures

Size of the client company
8.000 employees
qtec team size
2 regulatory affairs experts
Time between inquiry and project start
14 Days
Total project duration
4 months

Our expert knowledge for your success

We have in-depth, worldwide expertise in the Approval and registration of Medical Devices. I will answer your questions about the MDR and put together a team for your project upon request.

Contact +49 451 808 503 60
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