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      Zhuoyuan Tiancheng was invited to participate in the 11th cimdr medical device post marketing verification and risk management branch
      Cimdr was founded by China food and drug International Exchange Center (ccfdie) in 2010. The purpose of the meeting is to strengthen the publicity of China's medical device regulatory laws and policies, promote the experience exchange and cooperation between international medical device regulatory and evaluation departments, standardize the business order of enterprises, promote the exchange between enterprises and governments, and promote the application of new technical standards and technological achievements, so as to further improve the safety and effectiveness of medical devices.
      04-25
      卓遠天成員工2020魅力西雙版納之旅1
      云南,素有“彩云之南”、“旅游天堂”、“植物王國”之稱,因此她是美麗的。同時,作為我國“少數民族最多的省份“,她也是神秘的。恰逢金秋,我們卓遠天成公司組織員工踏上為期6天的云南西雙版納之旅,搜尋傳說中的“美麗”和“神秘”。
      04-25
      "Medical device risk and benefit analysis special topic - Shenzhen field" training activity is a complete success
      On October 23, 2020, Shenzhen medical device industry association and Zhuoyuan Tiancheng jointly held the "risk and benefit analysis of medical devices" - Shenzhen market as scheduled.
      04-25
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      中美關系變化,影響FDA 510K評審嗎?
      接觸FDA 510K申請的朋友也許留意到,近一兩年FDA在評審510K文件時,提出的問題越來越尖銳。聯系到近兩年的中美關系變化,例如美國打壓華為等事件,很多朋友推測,510K評審的加嚴,應該是美國對中國企業的一種打壓。
      04-25
      【新動態】2021財年美國FDA收費標準
      2020年7月31日,FDA公布2021財年醫療器械評審最新收費情況。
      04-25
      FDA:器械企業檢查過程和標準的評審與更新
      FDA發布本指南是為了符合FDA重新授權法案2017年(FDARA)(公共法115-52)章節 702(b)(2)部分,這部分法案指導FDA發布了關于官方將如何實施統一的檢查流程和標準,并且適用于除有因檢查外的境內和境外器械企業的檢查。
      04-25
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