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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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What Contact Lens Manufacturers Need to Know About the Master UDI-DI At the end of August 2025, the Medical Device Coordination Group (MDCG) published its revised guidance MDCG 2024-14 Rev.1. This document addresses the practical implementation of the so-called Master UDI-DI specifically for contact lenses and provides manufacturers with clear direction on how to ensure […]
Basic UDI-DI in transition scenarios: Can a BUDI be "empty"? 1. Can a Basic UDI-DI (transitional) exist without associated UDI-DI(s)? No – in EUDAMED, a basic UDI-DI is not registered in isolation. When registering Regulation Devices , the official EUDAMED user guide requires that a Basic UDI-DI is always submitted together with at least one […]
EU Launches “Apply AI”: €1 Billion for AI in Key Industries – Focus on Healthcare The European Commission is launching “Apply AI”, an investment package worth €1 billion, to accelerate the adoption of Artificial Intelligence in key industries and strengthen Europe’s technological sovereignty. President Ursula von der Leyen: “I want the future of AI to […]