深圳市卓遠天成咨詢有限公司是一家從事醫療器械國際咨詢的專業性咨詢 機構 ， 可為您提供各個國家或地區醫 療 器 械 上 市 注 冊 （ 如 ： 美 國FDA 510K、歐盟CE認證、加拿大CMDCAS認證、澳洲TGA認證等）、醫療器械質 量 體 系 審 查 （ 如 ： 美 國 QSR820驗 廠 、 中 國 醫 療 器 械 GMP（ 包 括 試 劑類）、日本GMP、巴西GMP、ISO13485等）等多種國際注冊及認證的咨詢/代理服務；也可為您提供醫療器械風險管理、軟件確認、滅菌確認、**評估、可用性確認等專題培訓服務。
公司的咨詢師及團隊擁有大、中型醫療器械制造企業從事高級管理職位的工作經驗及認證審核工作的專業背景，諳熟醫療器械制造企業的運作模式和行業特點，精通歐盟、美國、加拿大、澳大利亞、日本、巴西及中國醫療器械法律法規、產品標準、技術規范，在法規解讀、標準理解、產品測試、文件編寫、產品改進等方面具有較強的優勢。公司與英、德、瑞士等國家的知名國際認證機構和國內認證機構和測試機構具有良好的合作關系。公司的服務已得到客戶的廣泛認同。
公司文化：務實 創新。
公司理念：為客戶創造價值 為企業贏得未來 。
公司特點：專業 快捷 增值。
公司宗旨：誠信 合作 共贏。
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.
