臨床試驗服務
臨床試驗是醫療器械臨床評價過程中臨床數據的主要來源，是為評價醫療器械安全性、臨床性能或有效性而開展的系統性試驗或研究，包括可行性試驗、注冊臨床試驗及上市后臨床試驗。醫療器械臨床試驗應符合《醫療器械臨床試驗質量管理規范》（也稱為醫療器械GCP）要求，并在中國備案的醫療器械臨床研究機構開展。
醫療器械臨床試驗流程
我們的服務
臨床試驗方案設計
臨床機構篩選
臨床試驗立項及倫理申請
臨床試驗省局備案及人遺辦備案
臨床試驗監查
臨床試驗稽查
數據管理與統計分析
臨床試驗報告撰寫
臨床試驗數據整理
CRC服務
掃描下方的二維碼訂閱“CIRS醫械合規動態”！實時傳遞最新醫療器械監管法規動態，分享醫療器械注冊成功經驗及經典案例跟蹤醫療器械最新產品安全與法規監管動態，獲得最新一手資訊。
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