EUDAMED has been announced as mandatory — sign a contract in 2025 and secure a special discounted price.

Our Solutions

We are your competent partner for SAP services and solutions in IT

Unique Device Identification

UDI (Unique Device Identification) is a globally standardized system for the identification of medical devices ...................

Global Submission Portal

Unified platform for global FDA and EUDAMED submissions for eMDR and UDI

Global UDI Management

GUDI supports you in maintaining your UDI-relevant products and ensures seamless UDI data submission.

UDI Excel Cloud Validator

Validate UDI data for EUDAMED and FDA GUDID via table upload – with instant line-level feedback, export report, EU hosting and login via XSUAA/IAS, all without an SAP system.

Software Development

Companies are constantly exposed to change. We design and develop the right solution for your system.

GS1 Barcode Generator

Our GS1 barcode generator for SAP offers many benefits and is also easy to integrate into SAP. Read more ....................

What our customers say

Feedback from our customers and participants sets the direction for our actions. Participant surveys are therefore an essential element of our quality management

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.

Regulatory Affairs - Company Dentaurum

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!

Head of IT & ERP - Company seca gmbh & co. kg

We value every single one of our customers and guarantee individual solutions for every SAP project. Reliability and competence are the decisive factors for a successful cooperation