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 ...
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
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Here you will find the latest news
FDA ESG and Health Canada CESG: how medical device submissions have been transmitted electronically since April 2026 Existing FDA Gateway accounts can generally also be used for submissions to Health Canada. However, transmission is carried out using separate Health Canada processes, XML structures and routing information. Direct forwarding of GUDID UDI data to Canada is […]
EUDAMED: Manufacturers to Upload SSCP and SSP Documents Themselves in Future With its position paper MDCG 2026-4, the Medical Device Coordination Group has announced a significant change to the management of safety and performance reports in EUDAMED. In future, manufacturers will be expected to upload the validated SSCP and SSP documents, including the required translations, […]
swissdamed Deadlines and Registration Fees: Key Clarifications from Swissmedic Do manufacturers have to pay again every year for the same UDI-DI? Does it matter whether a product was registered before or after 1 July 2026? Does the transition period also apply to new products placed on the market for the first time after this date? […]