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 The ever-evolving medical device industry is subject to comprehensive guidelines designed to ensure the safety and efficacy of healthcare products. With…
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…
The introduction of the Medical Device Regulation brought a significant change: the assignment of Unique Device Identifiers (UDIs) for medical devices. This step was taken to improve the identification, traceability…
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…
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.…
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…
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…
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…
Europe IT Consulting receives successful ISO 9001 recertification without any "minor non-conformity" We are pleased to announce that Europe IT Consulting GmbH was successfully recertified by QS Zurich on July…