Learn in this short video how our global UDI software solution helps you ensure a smooth and successful UDI implementation.
The fastest way to get your UDI data to the authority databases such as EUDAMED, GUDID, SWISDAMED and more.
Learn More NowConsulting on how to maintain UDI data and how to submit it to the worldwide authorities
Learn More NowThe best SAP Add-On to manage your UDI data and submission to the authorities
Learn More NowThe best SAP Add-On to manage your UDI data and submission to the authorities
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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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MDR causes shortages of medical devices The introduction of Unique Device Identification (UDI) means that manufacturers of medical devices are obligated to provide a comprehensive range of product information to health authorities such as EUDAMED. This step has been taken to improve the identification, traceability, and monitoring of medical devices while also combating counterfeiting. Although […]
Introduction of the UDI system worldwide poses challenges for manufacturers to comply with Unique Device Identification regulations. These obligations are multifaceted, and the path to compliance is highly complex. UDI requirements vary from authority to authority, posing a continuous challenge for companies. Among these is the South Korean Medical Food and Drugs Safety (MFDS), the […]
Medical Mountains is a network and cluster initiative based in Tuttlingen, Germany. Focused on the realms of medical technology and life sciences, it serves as a platform bringing together companies, research institutions, startups, clinics, and other stakeholders to foster collaboration, innovation, and competitiveness within the industry. On March 14, 2024, Medical Mountains is hosting a […]