杭州甘德企業(yè)管理咨詢有限公司是專業(yè)服務(wù)醫(yī)療器械產(chǎn)品相關(guān)事務(wù)的技術(shù)咨詢服務(wù)機(jī)構(gòu)。
      “甘霖沛雨”是公司希望對(duì)企業(yè)的咨詢?nèi)绺柿睾团嬗暌粯幼虧?rùn)和充沛。
      “德才兼?zhèn)?rdquo;是公司要求職員工作時(shí)德放首位才華兼?zhèn)?。故公司取名甘德?/span>
        杭州甘德企業(yè)管理咨詢有限公司咨詢團(tuán)隊(duì)擁有來(lái)自生物、化學(xué)、機(jī)械、電氣、臨床醫(yī)學(xué)等專業(yè)背景的注冊(cè)、臨床專家，學(xué)歷100%本科以上，碩士以上的占60%；其中絕大多數(shù)人具有從事醫(yī)療器械相關(guān)工作超過(guò)8年的經(jīng)驗(yàn)。
        來(lái)自不同專業(yè)背景的人才，豐富而精深的專業(yè)知識(shí)及經(jīng)驗(yàn)，可以為我們的客戶提供最佳的解決方案 ，消除技術(shù)壁壘，解決醫(yī)藥相關(guān)技術(shù)難題，幫助企業(yè)以最少的費(fèi)用、最短的時(shí)間完成項(xiàng)目。高品質(zhì)的專業(yè)素養(yǎng)，保證了我們的團(tuán)隊(duì)能夠迅速應(yīng)對(duì)法規(guī)的變化、保持與客戶和監(jiān)管部門之間的溝通順暢。
        目前，我們的團(tuán)隊(duì)已經(jīng)與國(guó)內(nèi)外相關(guān)檢測(cè)機(jī)構(gòu)、官方機(jī)構(gòu)、醫(yī)療機(jī)構(gòu)建立了長(zhǎng)期的協(xié)調(diào)關(guān)系，為國(guó)內(nèi)外眾多企業(yè)客戶提供了“一站式”的注冊(cè)咨詢服務(wù)。公司成立以來(lái)， 先后成功服務(wù)了300余家江浙滬內(nèi)的醫(yī)療器械企業(yè)，陸續(xù)幫助生產(chǎn)企業(yè)成功拿到了近百個(gè)各類產(chǎn)品注冊(cè)證，以及成功建立符合法規(guī)考核需要和提升效益的企業(yè)體系。 

公司開(kāi)展：
         1、醫(yī)療器械產(chǎn)品注冊(cè)、變更、延續(xù)注冊(cè)（備案）咨詢
         2、醫(yī)療器械經(jīng)營(yíng)、生產(chǎn)許可證（備案證）辦理咨詢
         3、醫(yī)療器械無(wú)菌、植入等生產(chǎn)管理規(guī)范實(shí)施咨詢
         4、醫(yī)療器械出口歐盟CE咨詢
         5、醫(yī)療器械出口美國(guó)FDA咨詢
         6、醫(yī)療器械風(fēng)險(xiǎn)管理和臨床試驗(yàn)（豁免）咨詢
         7、醫(yī)療器械出口銷售證書、廣告許可備案、互聯(lián)網(wǎng)藥品信息服務(wù)證和交易證咨詢
         8、醫(yī)療器械分類界定咨詢
         9、年度醫(yī)療器械企業(yè)質(zhì)量管理體系顧問(wèn)咨詢
        10、醫(yī)療機(jī)構(gòu)執(zhí)業(yè)許可證咨詢
        在未來(lái)的發(fā)展中， 我公司將始終如一地堅(jiān)持以客戶為關(guān)注焦點(diǎn)，充分滿足法律法規(guī)要求，堅(jiān)持持續(xù)改進(jìn)，將優(yōu)質(zhì)的咨詢服務(wù)于更多的企業(yè)！
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.