ABOUT US_F&D Group

F&D Group

F&D Group specializes in providing global medical device manufacturers with consulting, certification, and training services related to medical device product standards, regulations, and certifications. Specific service areas include: EU Medical Device CE Marking Services (MDR & IVDR), Chinese Medical Device NMPA Registration and Consulting Services, US Medical Device FDA Registration and Consulting Services, ISO 13485 Medical Device Quality Management System Consulting and Certification Services, Medical Device Compliance Consulting and Training Services, UK UKCA Certification Services, and CE Certification Services for other products (MD, EMC, LVD, RED, etc.). F&D Group comprises three companies: Beijing Phoneix Testing Technology Co., Ltd., F&D Group, and the Sino-British-American (Beijing) International Technical Training Center.

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Beijing Phoenix Testing Technology Co., Ltd.

Beijing Phoenix Testing Technology Co., Ltd. is a technical service institution specializing in testing for medical device enterprises, committed to providing comprehensive and efficient testing and compliance solutions for domestic and international medical device manufacturers. Leveraging its professional technical team and extensive industry experience, the company assists clients in accelerating product market entry and enhancing market competitiveness. Backed by advanced laboratory equipment and a stringent quality management system, it covers multiple fields including medical device safety, electromagnetic compatibility (EMC), biocompatibility, and performance testing. The company offers testing services for a wide range of medical devices such as ultrasonic diagnostic equipment, fingertip pulse oximeters, ultrasonic lithotripters, thermotherapy devices, syringes, infusion sets, dental materials, and bone screws. These services span active medical devices, passive medical devices, in vitro diagnostic (IVD) products, invasive medical devices, and non-invasive medical devices, ensuring compliance with domestic and international regulatory requirements. With transparent workflows and the issuance of impartial and professional reports, Beijing Phoenix Testing Technology Co., Ltd. fulfills the testing needs of medical device enterprises throughout the product lifecycle, from research and development to registration.

F&D Group

F&D Group is an EU Authorized Representative agency based in Paris, France, specializing in EU representation services. Acting as the EU representative for non-EU registered medical device manufacturers, F&D Group assists manufacturers in fulfilling specific obligations under EU directives (MDR/IVDR) and regulatory requirements to ensure product compliance in the European market. Its service scope includes communication and coordination with EU regulatory authorities, handling EUDAMED database registration and product documentation on behalf of clients, guiding Unique Device Identification (UDI) registration, assisting in drafting and updating Clinical Evaluation Reports (CER) and risk management documentation, monitoring product safety, addressing consumer complaints and product recalls, and supporting enterprises in smoothly entering and maintaining stable operations within the EU market.

Sino-British-American (Beijing) International Technical Training Center

The Sino-British-American (Beijing) International Technical Training Center is a professional institution dedicated to certification, consulting, and training services in the medical device industry. Leveraging profound experience accumulated over years in management system consulting and a specialized expert team, it assists medical device enterprises in optimizing management systems, enhancing quality control standards, ensuring compliance of medical devices with international regulations, and strengthening market competitiveness. The center provides comprehensive services including ISO 13485 Medical Device Quality Management System certification, EU MDR/IVDR compliance certification consulting and training, Chinese medical device NMPA registration consulting, US medical device FDA registration consulting, domestic and international medical device regulatory integration consulting, supply chain compliance audits, and certification, training, and consulting services for other management systems (ISO 9001, ISO 14001, ISO 45001, ISO 27000, ISO 20000, etc.).