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醫療器械臨床稽查服務內容

  • 醫療器械臨床研究機構及人員資質審核
  • 醫療器械臨床試驗方案評估
  • 臨床項目現場稽查、研究中心稽查
  • 臨床研究基本文件稽查
  • 醫療器械注冊臨床評價資料稽查
  • 醫療器械臨床稽查報告編制
  • CAPA計劃提出及執行

醫療器械臨床稽查服務流程

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