CMC CONSULTING GROUP es un grupo de empresas consultoras de ámbito internacional, focalizada en asuntos regulatorios de productos sanitarios.
Con sede en España, ha establecido distintas oficinas en el Reino Unido, España, Suiza, China, Australia y EEUU. Cuenta con equipos técnicos profesionales de varios campos en todo el mundo, y puede proporcionar servicios personalizados para clientes internacionales basados en las condiciones reales del fabricante.
Noticias y novedades
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 notified [...]
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 [...]
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CMC Group, líderes en consultoría de medical devices, amplía su alcance con Cocolilo House SL, ofreciendo ahora soluciones integrales para inversores en el sector inmobiliario de la Costa del Sol.
