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
IVDR compliance deadline: how to prepare your Quality Management System (QMS) by May 26, 2025
With the entry into force of the Regulation (EU) 2017/746 (IVDR), manufacturers of in vitro diagnostic (IVD) medical devices face a series of new regulatory obligations. Among these, a key requirement is the implementation of a Quality Management System (QMS) [...]
UDI-DI mandatory from May 26, 2025: A guide for manufacturers
As of May 26, 2025, the UDI-DI (Unique Device Identifier – Device Identifier) will become mandatory for: Medical devices under MDR Class I In vitro diagnostic devices under IVDR Class B and C The obligation applies to all manufacturers, regardless [...]
Clinical Evaluation Report (CER) for MDR: Structure, Strategy, and Compliance
Understanding the Clinical Evaluation Report (CER) When it comes to medical devices, proving clinical safety and performance is not just good practice, it’s a regulatory requirement. The Clinical Evaluation Report (CER) is the document that systematically collects and evaluates all [...]
