Our Solutions

We combine UDI expertise, SAP integration and custom software development to create secure, practical solutions for your regulatory processes.

UDI and MedTech Consulting

We support MedTech companies from UDI strategy through system integration—with specialist, technical, and practical expertise.

Global UDI Submission Portal

Validate UDI data from Excel and securely submit it to EUDAMED, FDA GUDID, swissdamed, and other target systems.

Global UDI Management

Manage, validate, and approve UDI data directly in SAP—with modular connections to international regulatory systems.

UDI Excel Cloud Validator

Validate UDI Excel files for EUDAMED and GUDID directly in your browser—with row-level feedback.

GS1 Barcode Generator for SAP

Generate GS1 DataMatrix, GS1 Code 128, and other barcodes directly in SAP and flexibly integrate them into your forms.

Software Development

From concept to implementation: custom software solutions with flexible teams and direct collaboration.

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