Medical devices require clinical evaluation

According to Regulations on Supervisory Management of Medical Devices,

 Class II and/or Class III medical devices require clinical evaluation

Services

 Medical device clinical trial consulting and establish application protocol

 Medical device clinical trial training

 Medical device and IVD clinical trial

 Pre-Clinical Trial of medical device

 Clinical trial protocol design

 Data management and Biostatistics

 Medical device clinical trial report writing

 Clinical trial monitoring

 The strategy of Clinical evaluation

 Writing the clinical evaluation report (CER)

Clinical Trials Procedure