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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
卓远天成员工2020魅力西双版纳之旅1
云南,素有“彩云之南”、“旅游天堂”、“植物王国”之称,因此她是美丽的。同时,作为我国“少数民族最多的省份“,她也是神秘的。恰逢金秋,我们卓远天成公司组织员工踏上为期6天的云南西双版纳之旅,搜寻传说中的“美丽”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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中美关系变化,影响FDA 510K评审吗?
接触FDA 510K申请的朋友也许留意到,近一两年FDA在评审510K文件时,提出的问题越来越尖锐。联系到近两年的中美关系变化,例如美国打压华为等事件,很多朋友推测,510K评审的加严,应该是美国对中国企业的一种打压。
04-25
【新动态】2021财年美国FDA收费标准
2020年7月31日,FDA公布2021财年医疗器械评审最新收费情况。
04-25
FDA:器械企业检查过程和标准的评审与更新
FDA发布本指南是为了符合FDA重新授权法案2017年(FDARA)(公共法115-52)章节 702(b)(2)部分,这部分法案指导FDA发布了关于官方将如何实施统一的检查流程和标准,并且适用于除有因检查外的境内和境外器械企业的检查。
04-25
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