400-068-0287

杭州甘德企業管理咨詢有限公司是專業服務醫療器械產品相關事務的技術咨詢服務機構。
      “甘霖沛雨”是公司希望對企業的咨詢如甘霖和沛雨一樣滋潤和充沛。
      “德才兼備”是公司要求職員工作時德放首位才華兼備。故公司取名甘德。
        杭州甘德企業管理咨詢有限公司咨詢團隊擁有來自生物、化學、機械、電氣、臨床醫學等專業背景的注冊、臨床專家,學歷100%本科以上,碩士以上的占60%;其中絕大多數人具有從事醫療器械相關工作超過8年的經驗。
        來自不同專業背景的人才,豐富而精深的專業知識及經驗,可以為我們的客戶提供最佳的解決方案,消除技術壁壘,解決醫藥相關技術難題,幫助企業以最少的費用、最短的時間完成項目。高品質的專業素養,保證了我們的團隊能夠迅速應對法規的變化、保持與客戶和監管部門之間的溝通順暢。
        目前,我們的團隊已經與國內外相關檢測機構、官方機構、醫療機構建立了長期的協調關系,為國內外眾多企業客戶提供了“一站式”的注冊咨詢服務。公司成立以來, 先后成功服務了300余家江浙滬內的醫療器械企業,陸續幫助生產企業成功拿到了近百個各類產品注冊證,以及成功建立符合法規考核需要和提升效益的企業體系。 

 

公司開展:
         1、醫療器械產品注冊、變更、延續注冊(備案)咨詢
         2、醫療器械經營、生產許可證(備案證)辦理咨詢
         3、醫療器械無菌、植入等生產管理規范實施咨詢
         4、醫療器械出口歐盟CE咨詢
         5、醫療器械出口美國FDA咨詢
         6、醫療器械風險管理和臨床試驗(豁免)咨詢
         7、醫療器械出口銷售證書、廣告許可備案、互聯網藥品信息服務證和交易證咨詢
         8、醫療器械分類界定咨詢
         9、年度醫療器械企業質量管理體系顧問咨詢
        10、醫療機構執業許可證咨詢
        在未來的發展中, 我公司將始終如一地堅持以客戶為關注焦點,充分滿足法律法規要求,堅持持續改進,將優質的咨詢服務于更多的企業!
Hangzhou Gainder Enterprises Administration Consulting Co., Ltd. is specialized in offering technical consultation services regarding medical devices.
The company is so named because we hope to provide timely & sufficient help for our customers and  we expect our staff to be of moral integrity & professional competence.
Our staff members have rich expertise in medical device registration with such background as biology, chemistry, machinery, electrical engineering and clinical medicine. All of them hold Bachelor's degrees and 60% have Master's. Most of them have over 8 years of experience in medical device-related fields.
All these qualifications enable our staff to provide customers with the best solutions, remove technical barriers & solve medical problems for them,  and help them complete their projects with the least expenses & shortest time. The professionalism of our team ensures that we are capable of responding quickly to changes in regulations and keeping smooth communication with customers & regulatory authorities.
Currently we have established long-term coordinating relationship with relevant testing institutions inside & outside China, Chinese official bodies & medical facilities, and have offered one-stop registration consultation services to numerous Chinese & foreign enterprise customers. Since our company’s founding in 2010 we have provided services for more than 300 medical device enterprises in China and helped manufacturers obtain around 100  registration certificates for various products. In addition we have successfully set up enterprise systems for customers which meet requirements of regulation assessment and aim to improve effectiveness. 
The company’s main business includes consultation on:

  1. registration and modification & renewal of registration (record) for medical devices;
  2. applying for medical device operation & production  licenses (record certificates);
  3. implementation of Good Manufacturing Practice for sterile & implantable medical devices;
  4. CE marking for medical device export to European Union;
  5. FDA registration for medical device export to USA;
  6.  medical device risk management & clinical trials (exemption);
  7. Free Sales Certificates for medical devices, advertising licensing record, internet drug information service qualification & trading service qualification;
  8. medical device classification & definition;
  9. annual certification of quality management system for medical device enterprises;
  10. practicing license for medical facilities.

In the future our company will consistently provide customer-oriented services for more enterprises while meeting requirements of laws & regulations and continuously improving our work.

 

400-068-0287

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