License Biomedical CO., LTD is experience in medical devices register. Our consultants are experts at medical device registration, possesses more than 15-year experience as a consulting expert in health authorities (TFDA and CDE), and the Institutional Review Board in hospital.

         
                                     
We can provide you the professional and value-added assistance whether an existing medical device category or an innovative, high-risk medical device. From determining the application pathway to researching and documentary preparing our team can help, making you fully understand the regulations of medical devices, so that your product can be certified lightning-fast and then put on the market.

  Preparation of the Technical Documents      
●Risk Management Report(ISO 14971)
●Software Validation Report(IEC 62304)
●Human Factors Engineering Report(IEC 62366-1)
●Clinical Evaluation Report