New EUDAMED FAQ
New EUDAMED FAQ: Comprehensive Answers to Your Questions About the EU Medical Device Database We are pleased to announce that we have expanded our website with a new, comprehensive FAQ…
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FDA Unveils Next Generation ESG Interface: What You Need to Know
The FDA recently announced the launch of its Next Generation Electronic Submissions Gateway (ESG) interface, aiming to enhance the efficiency and user experience of electronic submissions for regulatory documents, including…
Medical Devices Market in India
Opportunities, Challenges, and Regulations India is one of the fastest-growing markets for medical devices globally. With an annual growth rate of approximately 16-17%, it presents significant opportunities for both domestic…
Successfully Audited for ISO 9001:2015 Certification
Successful Audit Completion at EUROPE IT Consulting GmbH Dear Business Partners, Colleagues, and Customers, We are pleased to announce that EUROPE IT Consulting GmbH has successfully passed the recent audit.…
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…
Europe IT Consulting GmbH supports the RSV Trompeter Bad Säckingen
We are proud to be the official main sponsor of the cycling club RSV Trompeter from Bad Säckingen for the year 2023. The RSV Trompeter Bad Säckingen 1897 e. V.…