The Regulations for the Supervision and Administration of Medical Devices (No. 739 Decree of the State Council) of China clearly sets out the requirements for clinical evaluation of medical devices.
Both the Medical Device Regulation (MDR) and the In Vitro Diagnostic Products Regulation (IVDR) issued by the EU require manufacturers to perform clinical evaluations as part of CE certification.
Our Services：
Establish clinical evaluation procedures
Establish clinical evaluation protocol
Identify equivalent products and perform equivalent comparison
Search the literature and other clinical data
Clinical data analysis
Complete clinical evaluation reports
