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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 FDA recently announced the launch of its Next Generation Electronic Submissions Gateway (ESG) interface, aiming to enhance the efficiency and user experience of electronic submissions for regulatory documents, including Unique Device Identification (UDI) data submissions.
Time is running out for the medical device industry to comply with the requirements of the Medical Device Regulation (MDR). To properly implement such complex regulations, it’s essential to have a clear understanding of the various terms involved. In the UDI regulations alone, there are many key terms that need to be known. That’s why […]
Opportunities, Challenges, and Regulations India is one of the fastest-growing markets for medical devices globally. With an annual growth rate of approximately 16-17%, it presents significant opportunities for both domestic and international manufacturers. The increasing demand for modern healthcare and advanced medical technology, coupled with a rapidly growing population, drives this growth.