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 ， 可为您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、确认、临床评估、可用性确认等专题培训服务。

公司的咨询师及团队拥有大、中型医疗器械制造企业从事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。公司与英、德、瑞士等国家的知名国际认证机构和国内认证机构和测试机构具有良好的合作关系。公司的服务已得到客户的广泛认同。

公司文化：务实 创新。
公司理念：为客户创造价值 为企业赢得未来 。
公司特点：专业 快捷 增值。
公司宗旨：诚信 合作 共赢。

Shenzhen Joyantech Consulting Co., Ltd is a professional consulting company engaged in Medical Device International Consultant, able to provide for you with many consulting services on Medical Device Marketing Registration Consultant in various countries or regions (such as FDA510k, CE certification, CMDCAS, TGA and the like), Medical Device Quality System Audit Consultant(such as QSR820, GMP for CFDA, Japan GMP, Brazil GMP, ISO 13485 and the like); and also able to provide for you with various Special Subjects Trainings such as Medical Device Risk Management, Software Validation, Sterilization Validation, Clinical Evaluation, Usability Validation and so on.

The consultants and experts of Joyantech boast the working experience in senior management positions of large-sized medical device companies, and professional background of engaging in medical device certification and audit, who is familiar with operation mode and characteristics of medical device industry, proficient in the Acts, Regulations, Standards, Technical Specifications, and has a strong advantage In aspects of Regulatory Guidance, the Standard Understanding, Product Testing, Files Compilation, Product Improvement, etc. Joyantech has good relations of cooperation with the well-known international certification bodies from Britain, Germany, Switzerland and other countries as well as national authoritative certification and test institutes. The company's services have been widely recognized by clients．

Company Culture: Pragmatism Innovation.
Company Philosophy: Create value for Clients ; Win Future for Enterprise.
Company Characteristics: Professional Swift Value-added.
Company Principles: Integrity Cooperation Win-win.