UDI GS1 Datamatrix Generator
SWISSDAMED Actor Module goes live (06.08.2024)
Bern, Switzerland - August 6, 2024 Swissmedic has announced the successful go-live of the Swissdamed Actors Module today. This marks a significant milestone in the regulatory framework for medical devices…
Over 107,000 UDI-DI submissions to EUDAMED
Basel, Switzerland – We at Europe IT Consulting GmbH are thrilled to announce a significant milestone in our ongoing efforts to support medical device manufacturers with compliance and regulatory requirements. (more…)
Outsourcing strategies for your company
Modern Outsourcing Strategies for Your Business Welcome to EUROPE IT Consulting, your reliable partner for efficient and cost-effective IT solutions. In today's globalized world, there are various approaches to outsourcing…
Medical Device Market in China: Current Developments and Interesting Details
Medical Device Market in China: Current Developments and Interesting Details The Chinese market for medical devices is experiencing dynamic growth and offers numerous opportunities for companies worldwide. Here are some…
Difference between Medical Device, Accessory, Spare Part, and Consumable according to MDR
Difference between Medical Device, Accessory, Spare Part, and Consumable according to MDR The European Medical Device Regulation (MDR 2017/745) provides clear definitions and requirements for various categories of products in…
The Requirements of an Effective QM-System for MedTech Companies
The Requirements of an Effective QM-System for MedTech Companies The worldwide introduction of the UDI system poses a challenge for manufacturers to comply with the regulations of the Unique Device…
MDR causes shortages of medical devices
MDR causes shortages of medical devices The introduction of Unique Device Identification (UDI) means that manufacturers of medical devices are obligated to provide a comprehensive range of product information to…
MFDS〡 Unique Device Identification in South Korea
Introduction of the UDI system worldwide poses challenges for manufacturers to comply with Unique Device Identification regulations. These obligations are multifaceted, and the path to compliance is highly complex. UDI…
Seminar Medical Mountains – Implementation of the EU MDR – EUDAMED
Medical Mountains is a network and cluster initiative based in Tuttlingen, Germany. Focused on the realms of medical technology and life sciences, it serves as a platform bringing together companies,…
Seminar Medical Mountains – Implementation of the EU MDR – EUDAMED
Medical Mountains is a network and cluster initiative based in Tuttlingen, Germany. Focused on the realms of medical technology and life sciences, it serves as a platform bringing together companies,…
