Since its establishment in 2017, Lingfu Technology has always focused on providing professional, efficient and customized technical consulting services for medical device manufacturers, and is committed to helping  companies launch safe, effective and regulatory compliant products to the global market. The company is headquartered in Shanghai, and has branches and offices in Hangzhou, Germany, the UK and the US, which can provide medical device manufacturers with one-stop regulatory consulting services for their products before launch. The company's main technical services cover: IVDR overseas clinical trials, EU CE certification, US FDA registration, China NMPA registration consultation, system certification, and authorized representative services of various countries.

Lingfu Technology gathers many senior experts and elites from medical device regulations, clinical and other fields, most of them have rich working experience in well-known notified bodies and regulatory departments of famous domestic and foreign medical device enterprises, and have an average of more than 10 years of experience in medical device regulations. From research and development to market launch and subsequent marketing services, Lingfu Technology's professional team will provide you with all-round global regulatory support.

Relying on the strategic layout of independent operation, Lingfu Technology has successfully established three authorized representative service companies in the international market. LLINS Technology Ltd in the United Kingdom, LLINS TECHNOLOGY INC in the United States and Llins Service & Consulting GmbH in Germany, which realizes the globalization of the business layout. At the same time, Lingfu Technology adheres to the principle of open cooperation and has established an exclusive cooperative clinical laboratory with Istinye University Hospital Liv Hospital Bahçeşehir in Turkey, aiming to deepen the cooperation between the two sides in the field of clinical trials, provide customers with more accurate and efficient services, and jointly promote the development of technical services.

OUR SERVICES

OUR ADVANTAGES

· Professional: The team brings together senior people and experts from leading  international notified bodies, medical device regulations, clinical and other fields with  a deep understanding of regulations.

· Fast: Close contact with notified agencies, familiar with the process of each notified  agency, and help enterprises to quickly apply for customs clearance and obtain  certificates.

· Confidentiality: Follow the commercial confidentiality agreement, focus on regulatory  services, and keep sensitive information of the enterprise strictly confidential.

· Customization: According to the existing foundation of the enterprise, recommend  the most suitable organization and personalized plan for the enterprise, so that the  project can be carried out in an orderly manner.

· Comprehensive: Provide all compliance solutions for product access to the main  market.

OUR MISSIONS

· Provide the best solutions for customers

· Ensure that the company's products comply with the regulatory standards of various countries

· Continuously improve services and update understanding and interpretation of regulations

· To meet customer needs and become a leader in the field of medical device registration