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About Europe IT Consulting GmbH
Your Partner for UDI and IT Solutions
Europe IT Consulting GmbH was founded in Basel in 2011.
We support companies with specialized IT and software solutions, combining technical expertise with many years of experience in the medical technology industry.
A particular focus of our company is Unique Device Identification (UDI). Since 2013, we have been developing solutions for the management, validation and submission of regulatory product data.
Today, our expertise includes SAP-integrated UDI solutions as well as web-based applications, regulatory data management, M2M data transmission and custom software development.
What Sets Us Apart
UDI SpecializationSince 2013, we have been intensively involved in the technical implementation of international UDI requirements for medical devices. |
Regulatory & ITWe combine regulatory requirements with data management, software development, SAP and automated submission processes. |
Long-Term CollaborationWe continuously develop our solutions and support many of our customers over many years. |
Our Areas of Expertise
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Unique Device Identification (UDI)
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Regulatory Data Management
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SAP Integration and SAP Development
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UDI Data Validation
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M2M Data Transmission
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Web-Based Software Solutions
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Custom Software Development
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Business Process Automation
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Company Milestones
| Year | Milestone |
| 2011 | Founded: Europe IT Consulting GmbH was founded by Ismail Demiralp. |
| 2012 | Growth: Hiring of the first employee and further expansion of the company. |
| 2013 | UDI: Development of the first customer-specific UDI solution. |
| 2014 | SAP UDI: Development of the first version of a UDI data management solution for SAP. |
| 2015 | GS1: Development of the UDI GS1 Barcode Generator for SAP to generate a GS1-compliant 2D DataMatrix code. |
| 2017 | EUDAMED: Start of the development of our EUDAMED UDI solution. |
| 2020 | Market Launch: Release of our UDI solution for EUDAMED. |
| 2022 | Opening of a company location in Türkiye, start of the development of the Global UDI Solution and ISO 9001 certification of the company. |
| 2023 | International Team: Further expansion of the team in Switzerland and Türkiye. |
| 2024 | Global UDI: Launch of the Global UDI Add-On for SAP. |
| 2025 | Global Submission Portal: Launch of our web-based platform for regulatory data submissions.
Closure of the Türkiye location and transfer of the employees to the headquarters. |
| 2026 | International Expansion: Further development of our solutions for global regulatory data processes and international authority platforms. |
Our Commitment
Regulatory requirements must not only be understood but also implemented reliably from a technical perspective. We therefore combine regulatory expertise with software development, data management and integration.
Our goal is to develop solutions that integrate reliably into our customers’ existing business processes and remain usable and maintainable over the long term.
Our Values
Quality:
Structured processes, traceable development and continuous improvement form the basis of our work.
Customer Focus:
Direct communication and long-term, partnership-based collaboration with our customers are particularly important to us.
Specialization:
We focus on areas in which we have built up in-depth professional and technical expertise.
Continuous Development:
Regulatory requirements and technologies are constantly evolving.
That is why we continuously develop both our expertise and our solutions.
Satisfied Customers
We have been supporting many of our customers for several years.
It is particularly important to us that our solutions prove themselves not only during implementation but also in long-term daily use.
When the FDA UDI requirements were introduced in 2016 with the Global Unique Device Identification Database (GUDID), we decided on a solution that would allow us to independently manage our UDI data, maintain it in SAP and submit it from there to the database using an SAP Add-On.
Mr Demiralp and his team successfully implemented this solution, and we were more than satisfied with it at the time and still are today.
With regard to the UDI requirements of the European Database on Medical Devices (EUDAMED), it was also important for us to continue this approach of independent data management and submission from SAP. We therefore once again chose the EUDAMED SAP Add-On from Europe IT Consulting.
Your Contacts
At Europe IT Consulting, you have direct contacts for technical, regulatory and commercial questions.
Short communication channels and personal support are an important part of our collaboration.
Ismail DemiralpFounder · Europe IT Consulting GmbH Contact for company management, software development, SAP and technical UDI solutions. |
Ugur MüldürSales & Marketing · UDI Solutions Contact for customer inquiries, UDI solutions, quotations and the commercial support of projects. |
Talk to us – we are happy to assist you!
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