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…
Important Update on EU Medical Device Regulation (EU MDR) Great news for medical device manufacturers! The EU MDR extension period offers some additional time for placing certain devices on the…
News in the MedTech sector: Our monthly newsletter keeps you up to date! We are pleased to announce that we are now publishing a monthly newsletter that will inform you…
The importance of the EUDAMED packaging system for the regulation of medical devices in the EU The EUDAMED packaging system is an indispensable part of the broader EUDAMED system, which…