醫(yī)療器械臨床試驗(yàn)及臨床評價(jià)

Clinical Trial and Clinical Evaluation

依據(jù)《醫(yī)療器械監(jiān)督管理?xiàng)l例》，

第Ⅱ類、第Ⅲ類醫(yī)療器械需要進(jìn)行臨床評價(jià)

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(wù)

Services

◆ 醫(yī)療器械臨床試驗(yàn)咨詢，制定相應(yīng)的整體解決方案

    Medical device clinical trial consulting and establish application protocol

◆ 醫(yī)療器械臨床試驗(yàn)相關(guān)培訓(xùn)

    Medical device clinical trial training

◆ NMPA II類、III類醫(yī)療器械及體外診斷試劑臨床試驗(yàn)

    Medical device and IVD clinical trial

◆ 醫(yī)療器械臨床前研究

     Pre-Clinical Trial of medical device

◆ 醫(yī)療器械臨床試驗(yàn)方案設(shè)計(jì)

     Clinical trial protocol design

◆ 醫(yī)療器械臨床試驗(yàn)數(shù)據(jù)管理與統(tǒng)計(jì)分析

     Data management and Biostatistics

◆ 醫(yī)療器械臨床試驗(yàn)報(bào)告撰寫

     Medical device clinical trial report writing

◆ 醫(yī)療器械臨床試驗(yàn)監(jiān)察

     Clinical trial monitoring

◆ 制定臨床評價(jià)的策略

      The strategy of Clinical evaluation

◆ 撰寫臨床評價(jià)報(bào)告（CER）

      Writing the clinical evaluation report (CER)

臨床試驗(yàn)流程

Clinical Trials Procedure