Osmunda Medical Device Consulting Organization (Guangzhou, Beijing, Shanghai, Suzhou, Shenzhen and Jinan) is the largest and most professional consulting company in the field of medical device in China. All Osmunda Consultant team members are from sizeable medical devices enterprises, well-known notified bodies and testing organizations. We are well versed in global various medical device quality system certification and product registration, such as SFDA registration, QSR 820 system, FDA registration, ISO 13485 system, CE certification etc. Our service includes clean room design, clinical trail, third party audit, training of regulations and standards, etc.
Our headquarters is in Guangzhou, and we have five branch offices (Beijing, Shanghai, Suzhou, Shenzhen, Jinan) which could provide high-speed local services and communication. By far, Osmunda has successfully assisted nearly 1,200 domestic and foreign enterprises in achieving various medical devices registration and certification. We will be your trustful partner and your most professional guide.
Services we provide: medical device registration consulting, ISO13485certification consulting, medical equipment certification consulting, FDA510K registration, the EU CE certification consulting, medical equipment production license consulting, registration certificate for Medical Devices Advisory, the medical equipment operating permit consulting, imported medical device registration consulting, medical equipment clinical trials of Medical Devices Advisory, training, the United States FDA registration,FDA QSR820 consulting advisory, FDA factory inspection advisory, the EU IVDD certification, the European MDD certification consulting, Canada CMDCAS registered consulting, Australian TGA registered consulting, Japan JPAL registered consulting, China SFDA registration, medical equipment GMP certification, the second party audit, the third party audit suppliers of medical equipment, medical equipment manufacturer factory, manufacturers of medical devices factory audit, medical equipment export inspection and so on.