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
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 majority [...]
COFEPRIS Medical Device Registration in Mexico: A Step-by-Step Guide
Mexico is one of the largest healthcare markets in Latin America. To sell medical devices or in vitro diagnostics (IVDs) in Mexico, foreign manufacturers must secure a Sanitary Registration (Registro Sanitario) from COFEPRIS (Comisión Federal para la Protección contra Riesgos [...]
EU Medical Device Classification: Class I, IIa, IIb & III Explained with Examples
Accurate risk classification forms the foundation of your entire regulatory strategy under the European Medical Device Regulation (EU) 2017/745 (MDR). Specifically, this classification dictates your compliance pathway in the European Union. Consequently, it impacts clinical data requirements and Notified [...]
