MDR 2017/745 - CONSULTING

CMC Medical Devices & Drugs S.L.

Málaga, Spain

CMC Consulting Group is an international company specializing in regulatory consulting and legal representation for medical devices. Its main focus is to help manufacturers of these products meet regulatory requirements and access global markets. Headquartered in Spain, with offices in countries such as the United Kingdom, Switzerland, China, Australia, and the United States, CMC offers personalized solutions based on each client's specific needs and market conditions. Their global technical team provides comprehensive support to ensure regulatory compliance and commercial success in any country. Services: CMC Consulting Group offers a full range of international representation services for medical devices, helping companies comply with local regulations and access key markets: Representation Representation in the EU : We act as your authorized representative in Europe, facilitating access to the European market and ensuring regulatory compliance at every step. Representation in the United Kingdom : As your Responsible Person in the UK, we ensure that your products comply with local regulations and are successfully launched in the British market. Representation in Switzerland : We provide authorized representation services in Switzerland, ensuring compliance with Swiss regulations and the effective introduction of products into the Swiss market. Representation in Australia : We act as your sponsor with the TGA in Australia, ensuring regulatory compliance and facilitating the entry of products into the Australian market. Representation in the United States : We act as your agent with the FDA in the United States, ensuring compliance with FDA requirements and facilitating successful entry into the U.S. market. Representation in China : We act as your authorized representative in China, facilitating the entry of your products into the Chinese market and ensuring compliance with local regulations. Free Sale Certificate (FSC) We issue Free Sale Certificates (FSC) to support the export of medical products and ensure compliance with international regulatory requirements. This certificate is essential to demonstrate that a product is legally available in its country of origin and facilitates its commercialization in foreign markets, complying with the regulations required by import authorities. Contract Research Organization (CRO) CMC Consulting Group offers Contract Research Organization (CRO) services, providing comprehensive assistance in the management of clinical trials. These services ensure the efficient and complete administration of all phases of clinical trials, meeting the highest regulatory and scientific standards, which facilitates the development and approval of medical devices in global markets. Consulting MDR Consulting : We assist with technical documentation to ensure full compliance with European Regulation MDR 2017/745 for medical devices. IVDR Consulting : We help prepare technical documentation to ensure in vitro diagnostic devices comply with the standards of the European IVDR 2017/746. ISO 13485 Consulting : We provide support in implementing and maintaining quality management systems for medical devices, ensuring compliance with the international ISO 13485 standard. EUDAMED Registration Consulting : We facilitate the registration process in the EUDAMED database, ensuring validation of manufacturers and products and complying efficiently with EU regulatory requirements. Global Product Registration Europe UK Switzerland Australia China USA Saudi Arabia Korea India Other Services Cosmetic Product Representation : We act as your Responsible Person for cosmetic products, ensuring compliance with European regulations and facilitating efficient access to the EU market. PPE Representation : We provide representation services for personal protective equipment (PPE), ensuring regulatory compliance and smooth entry into the European market. Legal Representation in Clinical Trials : We act as your legal representative in clinical trials, ensuring key aspects such as safety, credibility, and trial results are met.