Learn how our global UDI software solution helps ensure smooth and successful UDI implementation.
More detailsThe fastest way to submit your UDI data to regulatory databases such as EUDAMED, GUDID, SWISSDAMED and more.
Learn moreConsulting for managing UDI data and submitting it to UDI authorities
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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.
We have accompanied numerous projects during the introduction and further development of SAP. We are happy to make the experience gained in these projects available to your company. Our services range from conception and planning to architecture and implementation of individual solutions for your processes
Su socio para el cumplimiento global de UDI. Optimizamos y automatizamos la carga de datos en las bases de datos de registro de la UE, Suiza, Australia y EE. UU., garantizando el cumplimiento seguro de todos los requisitos regulatorios.
In order to meet the legal requirements of the FDA, manufacturers of medical technology products will have to comply with the UDI (Unique Device Identification) requirements in the future.
Your partner for global UDI compliance. We optimize and automate data uploads to the regulatory databases of the EU, Switzerland, Australia, and the USA, ensuring you meet all regulatory requirements with confidence.
We will be happy to advise you on all aspects of UDI (Unique Device Identification). From project scope to technical implementation. UDI label specifications, UDI master data management and GUDID/EUDAMED data ...
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Here you will find the latest news
EUDAMED deadline 28 May 2026: When a new UDI-DI brings forward the registration of the Basic UDI-DI In just a few weeks, on 28 May 2026, the use of the first four EUDAMED modules will become mandatory. These include, among others, the Actor Registration Module and the UDI/Devices Registration Module. With the publication of Commission […]
EUDAMED Status What do Draft, Discarded, Submitted, and Registered mean for UDI data? Anyone maintaining UDI data in EUDAMED or transmitting it via XML/M2M will regularly encounter different dataset statuses. In practice, understanding these statuses is crucial, as they influence not only data visibility but also whether records can be further edited, discarded, or finally […]
2026 increases the pressure to act for manufacturers 2026 will be operationally demanding for many MedTech companies. In the EU, the first four EUDAMED modules will become mandatory from 28 May 2026, namely Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance. In Switzerland, the registration of products, systems, and procedure packs in […]