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
Exciting Update: Istituto Superiore di Sanità Now Accredited for IVDR!
A new key player has been designated for the In Vitro Diagnostic Regulation (IVDR)! The Istituto Superiore di Sanità (NB 0373), based in Italy, has been recently accredited as a notified body. With this addition, the total number of [...]
Innovation and Regulation: How the AI Airlock Sandbox Can Help Medical Device Manufacturers!
Are you a developer or manufacturer of Artificial Intelligence (AI)-based medical devices? Then you should know about the latest opportunity offered by MHRA, the UK’s regulatory agency. They have opened applications for the AI Airlock regulatory sandbox, created to tackle [...]
Global IVD Device Registration: IVDR – 2017/746 Challenges
The IVDR (In Vitro Diagnostic Regulation 2017/746) has drastically changed the regulatory landscape in Europe for IVD devices. The new regulations not only impose stricter risk classifications but also demand rigorous clinical evaluation and post-market surveillance. What should you know [...]
CMC Group, leaders in medical device consulting, is expanding its reach with Cocolilo House SL, now offering comprehensive solutions for investors in the Costa del Sol real estate sector.