COMPANY · UDI · SAP · REGULATORY DATA
Europe IT Consulting: UDI Software and SAP Integration from Basel
Our ambition: to be the best UDI service provider for medical device manufacturers – and a first-class SAP and software partner for companies across a wide range of industries. Since 2013, we have been combining SAP, cloud and Excel into end-to-end solutions for EUDAMED, FDA GUDID, swissdamed and AusUDID.
Europe IT Consulting was founded in Basel in 2011 and has been developing UDI solutions since 2013. The portfolio ranges from SAP-integrated applications and Excel validation in the cloud to web-based submission processes and individual consulting.
Europe IT Consulting has already submitted
500,000
UDI data records to regulatory authorities via M2M.
About Europe IT Consulting
Europe IT Consulting GmbH is a Swiss software and consulting company headquartered in Basel. We develop specialized IT and software solutions, combining in-depth technical expertise with many years of experience in medical technology.
Since 2013, Unique Device Identification (UDI) has been a particular focus. We help medical device companies manage and validate regulatory product data in a structured manner and transmit it to international target systems through suitable technical channels.
We look beyond individual interfaces and consider the entire data process: from SAP, Excel or another structured source through validation and approval to authority feedback and ongoing maintenance. We support many customers over many years – from concept and implementation through further development and ongoing operations.
Since 2011
Swiss company headquartered in Basel.
UDI since 2013
Solutions for managing, validating and transmitting regulatory product data.
SAP and Cloud
SAP-integrated solutions and web applications for processes outside SAP.
ISO 9001
Certified quality management and continuous improvement.
CROSS-INDUSTRY IT EXPERTISE
More than Medical Technology
UDI and regulatory product data are a core specialization of Europe IT Consulting. However, we also apply our experience in SAP, data management, integration, forms development, process automation and custom software development to companies outside the medical technology sector.
Our customer and project references come from a wide range of sectors:
Pharmaceuticals and Healthcare
Industry and Manufacturing
Retail, Consumer Goods and Textiles
Food and Nutrition
Transport and Logistics
Real Estate and Services
Why Europe IT Is One of the Strongest UDI Specialists
Global in outlook, personal in service: we aim to be the first choice for demanding UDI projects and tailored digital solutions – from strategic consulting to productive operations.
UDI Expertise at the Highest Level
Since 2013, we have been implementing international UDI requirements from a technical perspective. This specialization makes us a highly experienced partner for complex regulatory data processes.
Global UDI Expertise from a Single Source
We combine regulatory requirements, data models, validation rules, SAP processes, cloud applications and automated transmission channels into an end-to-end solution.
Service That Sets Standards
Direct communication, personal support and long-term responsibility: we accompany our customers from the initial idea through secure ongoing operations.
Our Areas of Expertise
Regulatory Data Management
SAP Integration and Development
UDI Data Validation
M2M Data Transmission
Web-Based Software
Custom Software Development
Process Automation
What an Integrated UDI Process Delivers
A Clear Path from Source to Target System
Data source, validation rules, approvals, transmission channel and authority feedback are treated as one connected process.
A Solution That Fits the Starting Point
A team with master data in SAP needs a different approach from a team working with Excel. Source, data volume, frequency and target system determine the architecture.
Clear Separation of Validation and Submission
Validation identifies data problems before submission; it does not constitute acceptance by an authority. Keeping the two separate makes responsibilities and processing statuses traceable.
Traceability in Ongoing Operations
Depending on the product and module, validations, approvals, activity logs, publication statuses and feedback can be incorporated into the workflow.
Our UDI Solutions
The right solution depends on where the data is managed, how it needs to be validated or submitted, and how subsequent operations are organized.
GUDI – Global UDI Add-On for SAP
For companies that want to maintain, validate, approve and transmit UDI data within their SAP environment. GUDI is modular by authority and uses an interface based on SAP Fiori and SAPUI5.
Global Submission Portal
Web platform for importing, validating and managing structured submission processes. Depending on the module, it can display statuses, errors, authority responses, activity logs and publication statuses.
UDI Excel Cloud Validator
SaaS application on SAP BTP for validating Excel files for EUDAMED and FDA GUDID. It provides row-level errors and warnings, correction guidance and an exportable report. A customer-owned SAP system is not required. The Validator does not transmit the data itself.
UDI Consulting and Data Services
Professional and technical support for data analysis, process definition, data preparation, selection of the transmission channel and implementation of a suitable solution. Project-based submission services can also be agreed.
Regulatory Target Systems
Europe IT provides processes and modules for various international systems. The functions and transmission channels available are confirmed before the project begins for the selected solution and target system.
| Market and System | Processes Covered in the Portfolio |
|---|---|
| European Union · EUDAMED | UDI data under MDR/IVDR and, in the relevant modules, Vigilance/MIR processes. |
| USA · FDA | UDI data for GUDID and eMDR reports in the corresponding module. |
| Switzerland · Swissmedic/swissdamed | Preparation and structured processes for swissdamed UDI data. |
| Australia · TGA/AusUDID | Preparation and workflows for AusUDID data. |
How a UDI Project Is Structured
- Assess the starting point: Data sources, markets, products, responsibilities and change frequency are recorded.
- Define the data model: Existing data is mapped to the fields and relationships of the relevant target system.
- Improve data quality: Missing mandatory fields, contradictory values and implausible relationships are identified.
- Select the solution path: Together, we determine whether GUDI, the Global Submission Portal, the UDI Excel Cloud Validator or a project-based service is suitable.
- Validate, approve and process: The defined steps are carried out via Excel, XML or M2M/Data Exchange, provided the target system and module support them.
- Manage changes: Corrections, product changes, new rules and authority responses are incorporated into the lifecycle.
PUBLISHED PRODUCT
UDI Excel Cloud Validator on SAP.com
SAP.com lists the UDI Excel Cloud Validator as a product of Europe IT Consulting GmbH. The profile describes a SaaS solution on SAP Business Technology Platform for validating EUDAMED and FDA GUDID Excel files, with row-level results, correction guidance and exportable reports.
Our Journey Since 2011
From an initial customer-specific UDI solution, an internationally oriented portfolio of products and services has emerged through several stages of development.
| Year | Milestone |
|---|---|
| 2011 | Ismail Demiralp founds Europe IT Consulting GmbH in Basel. |
| 2012 | The company’s team begins to grow with its first employee. |
| 2013 | Development of the first customer-specific UDI solution. |
| 2014 | Development of the first UDI data management solution for SAP. |
| 2015 | Development of the UDI GS1 Barcode Generator for SAP to generate GS1-compliant 2D DataMatrix codes. |
| 2017 | Start of development of a UDI solution for the European Database on Medical Devices, EUDAMED. |
| 2020 | Market launch of the EUDAMED solution. |
| 2022 | Opening of a location in Türkiye, start of development of a global UDI solution and ISO 9001 certification. |
| 2023 | Expansion of the team in Switzerland and Türkiye. |
| 2024 | Introduction of the Global UDI Add-On for SAP. |
| 2025 | Introduction of the web-based Global Submission Portal. The location in Türkiye is closed; the employees working there are transferred to the headquarters and integrated into the team. |
| 2026 | International expansion and further development of solutions for global regulatory data processes and international authority platforms. |
Our Ambition and Our Values
Regulatory requirements must not only be understood but also implemented reliably from a technical perspective. Our goal is to create solutions that integrate into existing business processes and remain usable, traceable and maintainable over the long term.
We continuously monitor technological and regulatory changes, expand our expertise and incorporate relevant developments into our products and services. This allows us to support our customers reliably not only during implementation, but also with later adaptations.
Quality
We work with structured processes, traceable development and continuous improvement. Our ISO 9001-certified quality management system supports this commitment.
Customer Focus
We rely on direct communication, personal support and collaborative partnership – from consulting and implementation through ongoing operations.
Specialization
We focus on areas where in-depth regulatory expertise, MedTech experience and technical know-how come together.
Continuous Development
We continuously adapt our expertise, products and services to new regulatory requirements and technological developments.
Our Partner Network
High-quality consulting, reliability and strong interpersonal skills are the basis of successful projects for us. Together with specialized partners, we can combine consulting, conception, proven software products and custom software development from a single source.
The network complements our own UDI, SAP and software expertise in clearly defined specialist areas. This gives customers coordinated solutions without sacrificing personal support or clear responsibilities.
SAP
Europe IT Consulting is an SAP Build Partner. The partnership supports the development and integration of proprietary software solutions in the SAP environment.
SAP Partner ID: 1409437 · View Partner Profile
OPAL Labelmanagement
OPAL is a provider and system integrator for label management and AutoID. SAP expertise, field-proven solutions and adaptability to regulatory requirements support compliance, quality, flexibility and efficiency throughout the supply chain.
Kern AG
Kern AG develops software for planning and controlling in finance, sales and logistics. Allevo connects Excel and SAP; Sparks enables corresponding planning processes independently of SAP as well.
Long-Term Collaboration from the Customer Perspective
Our solutions are designed to prove themselves not only during implementation but also in long-term daily use. Two published customer testimonials show how this collaboration is experienced.
seca gmbh & co. kg
“Quality and efficiency are top priorities at seca. With the support of Europe IT Consulting GmbH in SAP and Adobe form development, we have achieved a significant improvement in both areas. The integration of their FDA and EUDAMED add-ons was a seamless process, and the benefits we gain from them are visible every day. A heartfelt thank you to the Europe IT Consulting team for their outstanding work and support!”
Head of IT & ERP
seca gmbh & co. kg
Dentaurum GmbH & Co. KG
“When the FDA’s UDI requirements were introduced in 2016 with the Global Unique Device Identification Database (GUDID), we chose a solution that would allow us to manage our UDI data independently through an SAP add-on, maintain it in SAP and transmit it from there to the database. Mr Demiralp and his team implemented this solution successfully, so we were more than satisfied at the time and still are today. For us, it was also important in the context of the UDI requirements of the European Database on Medical Devices (EUDAMED) to continue this approach of independent data management and transmission from SAP. We therefore once again chose Europe IT Consulting’s EUDAMED SAP Add-On.”
Regulatory Affairs
Dentaurum GmbH & Co. KG
Customer and Project References
Geuder AG
Lohmann & Rauscher
NTI New Technology Instruments
EDENTA · Edenta Etablissement
MAQUET – Getinge Group
Migros-Genossenschafts-Bund
Bell Schweiz AG
FORESTADENT · Bernhard Förster GmbH
SBB CFF FFS
seca gmbh & co. kg
VITA Zahnfabrik
Sandoz
Olympus
Zimmer Biomet
Ypsomed
Rieter
Dentaurum GmbH & Co. KG
HUBER+SUHNER AG
KRH Klinikum Region Hannover
Mobimo Holding AG
TALLY WEiJL
Carl Zeiss AG
Döhler
Deloitte Schweiz
BUSCH & CO. GmbH & Co. KG
BIP Biomedizinische Instrumente und Produkte GmbH
ChM sp. z o.o.
DENDIA · Dendia GmbH
Dr. Schumacher GmbH
EIZO
fashy GmbH
HOGGI GmbH
JOTA AG Rotary Instruments
Klaveness Footwear
LINCOTEK MEDICAL
Medacta International
MEISINGER · Hager & Meisinger GmbH
Perpedes GmbH
Davis Schottlander & Davis Ltd
SOMNOmedics AG
TBR Dental
TIBA Group
UROMED Kurt Drews KG
AbbVie
Burkart Medizintechnik AG
DMG Dental · DMG Chemisch-Pharmazeutische Fabrik GmbH
Evolution Marketing AG
Inopharm GmbH
Lobeck Medical AG
Occuity Ltd
optimed Medizinische Instrumente GmbH
Ortoma AB
PARI GmbH
pritidenta® GmbH
q.beyond AG
optimed Medizinische Instrumente GmbH
Your Contacts
Direct contacts are available for technical, regulatory and commercial questions. Short communication channels are an integral part of how we work together.
Ismail Demiralp
Founder and Managing Director
Contact for corporate management, software development, SAP and technical UDI solutions.
Europe IT Consulting GmbH
Ugur Müldür
Sales and Marketing · UDI Solutions
Contact for customer inquiries, UDI solutions, quotations and the commercial support of projects.
Europe IT Consulting GmbH
Europe IT Consulting GmbH
Steinentorstrasse 35, 4051 Basel, Switzerland
Contact Us · Follow us on LinkedIn and YouTube.
Frequently Asked Questions about Europe IT, Our Industries and UDI Solutions
When It Comes to UDI, You Should Not Compromise
Choose a specialized partner that understands regulatory requirements, data and technology as a whole. Together, we develop the strongest path for your UDI data – in SAP, in the cloud or based on Excel.
