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
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 [...]
MDSAP Explained: One Audit for 5 Markets (US, Canada, Brazil, Japan, Australia)
Obtaining regulatory approval in multiple international markets often means dealing with a barrage of redundant Quality Management System (QMS) audits. For manufacturers looking to expand globally, this replication of effort consumes valuable time, capital, and resources. The Medical Device [...]
FDA QMSR Explained: What the New Quality System Regulation Means (and How to Prepare)
The wait is over, and the transition window is officially closed. On February 2, 2026, the FDA fully enacted its new Quality Management System Regulation (QMSR). This update completely overhauls the legacy 21 CFR Part 820 (QSR), replacing old, US-centric rules with an internationally [...]
