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About the Company

深圳市卓远天成咨询有限公司是一家从事医疗器械国际咨询的专业性咨询机构。提供各个国家或地区医疗器械上市注册(如:美国FDA 510K、欧盟CE认证、加拿大CMDCAS认证、澳洲TGA认证等)、医疗器械质量体系审查(如:美国QSR820验厂、中国医疗器械GMP(包括试剂类)、日本GMP、巴西GMP、ISO13485等)等多种国际注册及认证的咨询、代理服务;也可为您提供医疗器械风险管理、软件确认、灭菌确认、临床评估、可用性确认等专题培训服务。卓远天成公司的咨询师及专家团队拥有大、中型医疗器械制造企业从事高级管理职位的工作经验及认证审核工作的专业背景,谙熟医疗器械制造企业的运作模式和行业特点,精通欧盟、美国、加拿大、澳大利亚、日本、巴西及中国医疗器械法律法规、产品标准、技术规范,在法规解读、标准理解、产品测试、文件编写、产品改进等方面具有较强的优势。卓远天成公司与英、德、瑞士等国家的知名国际认证机构和国内权威认证机构和测试机构具有良好的合作关系。

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Business Registration

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Operating Status: 开业
Registered Capital: 100万(元)
Legal Representative: 付宏涛
Date Established:
Credit Code: 91440300797993678G
Registered Address: 深圳市南山区桃源街道平山社区留仙大道4168号众冠时代广场A座1713A

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