When the UDI requirements of the FDA were introduced in 2016 with the Global Unique Device Identification Database (GUDID), we decided on the solution of being able to manage our UDI data independently using a SAP add-on, maintain it in SAP and transfer it from there to the database. Mr. Demiralp and his team were able to implement this solution successfully, so that we were more than satisfied then and still are.

For us it was also within the framework of the UDI requirements of the European database for Medical products (EUDAMED) it is important to continue on this path of independent data management and transfer from SAP. That's why we decided this time to use the EUDAMED SAP Add-On from Europe IT Consulting.

At seca, quality and efficiency come first. With the support of Europe IT Consulting GmbH in SAP and Adobe form development, we have a significant increase in both aspects achieved.
The integration of their FDA and EUDAMED Add-On was a seamless process, and the benefits we derive from it are visible every day.

A big thank you to the team from Europe IT Consulting for their excellent work and support!