Find out how our global UDI software solution helps you ensure a smooth and successful UDI implementation
Learn More NowThe fastest way to get your UDI data to the authority databases such as EUDAMED, GUDID, SWISSDAMED and more.
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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.
In order to comply with the legal requirements of the FDA, manufacturers of medical technology must in future publish their products in GUDID in good time.
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 offer in-house training for successful implementation with SAP Interactive Forms by Adobe ©. The latest form technology in SAP has significant advantages over SapScript and SmartForms.
Manufacturers of medical devices have for the most part already met the requirements of the FDA. The European database, EUDAMED for short, is now due for completion and brings with it new ...
Zebra printers are the first choice when it comes to label printing in the SAP environment. With the existing SAP device types AZPL203 and AZPL300, the printers can be easily connected to the SAP system.
It is the latest forms technology from SAP. SAP customers today rely on future-oriented forms technology, replacing existing forms technologies such as SapScript and SmartForms.
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
The full UDI lifecycle – everything from a single source The path to full UDI compliance can be understood as a data cycle: UDI master data → Traceability → Vigilance Each building block matters, but only their interaction creates tangible value for manufacturers, authorities, and patients.
When does the UDI-DI status need to be changed? In EUDAMED, the status (not the country end data) decides whether a device is considered "On the EU market" or "No longer placed on the EU market". Anyone who terminates the first placing on the market throughout the EU must set the status to "No longer…" […]
Do custom-made devices (CMD) have to be registered in EUDAMED – and what about cases of vigilance? What are custom-made products according to the MDR? Please also read our article Customization according to MDR (2017/745) The question of whether “custom-made devices” must be registered in the EUDAMED often reaches us and also causes some confusion […]