杭州甘德企业管理咨询有限公司是专业服务医疗器械产品相关事务的技术咨询服务机构。
“甘霖沛雨”是公司希望对企业的咨询如甘霖和沛雨一样滋润和充沛。
“德才兼备”是公司要求职员工作时德放首位才华兼备。故公司取名甘德。
杭州甘德企业管理咨询有限公司咨询团队拥有来自生物、化学、机械、电气、临床医学等专业背景的注册、临床专家，学历100%本科以上，硕士以上的占60%；其中绝大多数人具有从事医疗器械相关工作超过8年的经验。
来自不同专业背景的人才，丰富而精深的专业知识及经验，可以为我们的客户提供最佳的解决方案 ，消除技术壁垒，解决医药相关技术难题，帮助企业以最少的费用、最短的时间完成项目。高品质的专业素养，保证了我们的团队能够迅速应对法规的变化、保持与客户和监管部门之间的沟通顺畅。
目前，我们的团队已经与国内外相关检测机构、官方机构、医疗机构建立了长期的协调关系，为国内外众多企业客户提供了“一站式”的注册咨询服务。公司成立以来， 先后成功服务了300余家江浙沪内的医疗器械企业，陆续帮助生产企业成功拿到了近百个各类产品注册证，以及成功建立符合法规考核需要和提升效益的企业体系。
公司开展：
1、医疗器械产品注册、变更、延续注册（备案）咨询
2、医疗器械经营、生产许可证（备案证）办理咨询
3、医疗器械无菌、植入等生产管理规范实施咨询
4、医疗器械出口欧盟CE咨询
5、医疗器械出口美国FDA咨询
6、医疗器械风险管理和临床试验（豁免）咨询
7、医疗器械出口销售证书、广告许可备案、互联网药品信息服务证和交易证咨询
8、医疗器械分类界定咨询
9、年度医疗器械企业质量管理体系顾问咨询
10、医疗机构执业许可证咨询
在未来的发展中， 我公司将始终如一地坚持以客户为关注焦点，充分满足法律法规要求，坚持持续改进，将优质的咨询服务于更多的企业！
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:
- registration and modification & renewal of registration (record) for medical devices;
- applying for medical device operation & production licenses (record certificates);
- implementation of Good Manufacturing Practice for sterile & implantable medical devices;
- CE marking for medical device export to European Union;
- FDA registration for medical device export to USA;
- medical device risk management & clinical trials (exemption);
- Free Sales Certificates for medical devices, advertising licensing record, internet drug information service qualification & trading service qualification;
- medical device classification & definition;
- annual certification of quality management system for medical device enterprises;
- 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.
