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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.
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The EU has designated several UDI issuing entities (Issuing Entities) to provide manufacturers with various options for generating and managing their Unique Device Identifiers (UDIs). The currently recognized entities are: GS1 AISBL Health Industry Business Communications Council (HIBCC) ICCBBA Informationsstelle für Arzneispezialitäten (IFA GmbH) Each of these organizations has its own standards and methods for […]
What is a “New Device” according to MDR and IVDR? Introduction The Medical Device Regulation (MDR, EU 2017/745) and the In Vitro Diagnostic Regulation (IVDR, EU 2017/746) have significantly tightened the requirements for medical devices and in vitro diagnostics. In this context, the question arises: What qualifies as a “New Device” under MDR and IVDR? […]
What is an “Active Device” according to MDR and IVDR? Introduction The Medical Device Regulation (MDR, EU 2017/745) and In Vitro Diagnostic Regulation (IVDR, EU 2017/746) have tightened the requirements for medical devices and in vitro diagnostics (IVDs) in Europe. One key classification concerns “Active Devices” (active medical devices). But what exactly are “Active Devices,” […]