醫療器械臨床試驗及臨床評價

Clinical Trial and Clinical Evaluation

依據《醫療器械監督管理條例》，

第Ⅱ類、第Ⅲ類醫療器械需要進行臨床評價

According to Regulations on Supervisory Management of Medical Devices,

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

我們的服務

Services

◆ 醫療器械臨床試驗咨詢，制定相應的整體解決方案

    Medical device clinical trial consulting and establish application protocol

◆ 醫療器械臨床試驗相關培訓

    Medical device clinical trial training

◆ NMPA II類、III類醫療器械及體外診斷試劑臨床試驗

    Medical device and IVD clinical trial

◆ 醫療器械臨床前研究

     Pre-Clinical Trial of medical device

◆ 醫療器械臨床試驗方案設計

     Clinical trial protocol design

◆ 醫療器械臨床試驗數據管理與統計分析

     Data management and Biostatistics

◆ 醫療器械臨床試驗報告撰寫

     Medical device clinical trial report writing

◆ 醫療器械臨床試驗監察

     Clinical trial monitoring

◆ 制定臨床評價的策略

      The strategy of Clinical evaluation

◆ 撰寫臨床評價報告（CER）

      Writing the clinical evaluation report (CER)

臨床試驗流程

Clinical Trials Procedure