医疗器械临床试验及临床评价

医疗器械临床试验及临床评价

Clinical Trial and Clinical Evaluation

依据《医疗器械监督管理条例》，

第Ⅱ类、第Ⅲ类医疗器械需要进行临床评价

According to Regulations on Supervisory Management of Medical Devices,

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

我们的服务

Services

◆ 医疗器械临床试验咨询，制定相应的整体解决方案

    Medical device clinical trial consulting and establish application protocol

◆ 医疗器械临床试验相关培训

    Medical device clinical trial training

◆ NMPA II类、III类医疗器械及体外诊断试剂临床试验

    Medical device and IVD clinical trial

◆ 医疗器械临床前研究

     Pre-Clinical Trial of medical device

◆ 医疗器械临床试验方案设计

     Clinical trial protocol design

◆ 医疗器械临床试验数据管理与统计分析

     Data management and Biostatistics

◆ 医疗器械临床试验报告撰写

     Medical device clinical trial report writing

◆ 医疗器械临床试验监察

     Clinical trial monitoring

◆ 制定临床评价的策略

      The strategy of Clinical evaluation

◆ 撰写临床评价报告（CER）

      Writing the clinical evaluation report (CER)

临床试验流程

Clinical Trials Procedure