Significant EUDAMED Update: New Timeline
Significant EUDAMED Update: New Timeline Heads up, everyone! There's been a shift in plans. EUDAMED's full functionality is now slated for Q2 2027. In late October 2023, the European Commission…
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Webinar: Global UDI Compliance – Effective Implementation of Data Management and Labeling
Dive with us into the world of Unique Device Identification (UDI) and discover how to overcome regulatory challenges and successfully implement efficient processes in your organization. Our upcoming webinar will…
Clinical Size Types : Meaning and integration in EUDAMED
Clinical Size Types : Meaning and integration in EUDAMED The introduction of Unique Device Identification (UDI) has resulted in medical device manufacturers being required to provide health authorities such as…
Storage & Handling Condition: Key aspects and their significance
Storage & Handling Condition: Key aspects and their significance The ever-evolving medical device industry is subject to comprehensive guidelines designed to ensure the safety and efficacy of healthcare products. With…
Webinar: Global UDI Compliance – Effective Implementation of Data Management and Labeling
Dive with us into the world of Unique Device Identification (UDI) and discover how to overcome regulatory challenges and successfully implement efficient processes in your organization. Our upcoming webinar will…
Medical Mountains – Ismail Demiralp becomes new spokesperson
Medical Mountains - Network for medical technology Medical Mountains is a network and cluster initiative based in Tuttlingen, Germany. The network focuses on the field of medical technology and life…
EMDN codes in EUDAMED: functionality and use
The European Database for Medical Devices (EUDAMED) plays a crucial role in the regulation and surveillance of medical devices within the European Union. With the introduction of the regulations (Art.…
Download our new EU-MDR Whitepaper
We are pleased to present you our brand new whitepaper! Thanks to the collaboration between Europe IT Consulting GmbH and Opal Labelmanagement, we have created this comprehensive guide that provides…
FDA warns manufacturers about GUDID data discrepancies
The U.S. Food and Drug Administration (FDA) has taken a proactive step to ensure the accuracy and compliance of medical device information by notifying medical device manufacturers of potential discrepancies…
The importance and implementation of critical warnings in the EUDAMED
Critical warnings: Essential aspects and their significance The evolving world of medical devices is subject to complex regulations designed to ensure the safety and effectiveness of healthcare products. With the…