CMC CONSULTING GROUP is an international group of consulting firms focused on regulatory affairs for medical devices.
Based in Spain, it has established various offices in the United Kingdom, Spain, Switzerland, China, Australia, and the USA. With professional technical teams from various fields around the world, it can provide personalized services for international clients based on the actual conditions of the manufacturer.
News and Updates
EUDAMED Roll-Out: Timeline, Mandatory Modules and Key Deadlines for Manufacturers
EUDAMED, the European Database on Medical Devices, is now entering a new phase. Since 28 May 2026, four EUDAMED modules have been mandatory to use: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance. For manufacturers of [...]
EUDAMED Registration – A Comprehensive Guide for Manufacturers
EUDAMED registration is an important part of placing and managing medical devices on the European Union market under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The European Database on Medical Devices (EUDAMED) brings together [...]
FDA 510(k) Clearance: Process, Timeline and Common Pitfalls
Entering the United States healthcare market represents a massive growth opportunity for medical device manufacturers worldwide. However, gaining access to this market requires navigating strict regulatory pathways overseen by the U.S. Food and Drug Administration (FDA). For the vast [...]
