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
Switzerland adopts EU rules on electronic instructions for use for medical devices
On 8 August 2025, Swissmedic announced the immediate implementation of Commission Implementing Regulation (EU) 2025/1234 on electronic instructions for use (e-IFUs). The measure aligns Switzerland with the latest EU requirements and extends the permitted scope for e-IFUs when devices [...]
New EU manual on borderline & classification of medical devices and IVDs
The European Union has released the 4th edition of the Manual on Borderline and Classification for Medical Devices and In Vitro Diagnostic Medical Devices (IVDs). This update provides practical, case-based guidance to help stakeholders determine whether a product falls under [...]
Australia’s approach to regulating software-based medical devices
The rapid rise of digital health technologies is transforming healthcare delivery. Software is no longer just an accessory to medical devices, it can operate as a medical device on its own. To guarantee safety and performance, the Therapeutic Goods Administration [...]
