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质量体系咨询服务
欧盟医疗器械CE咨 询服务
美国FDA注册、 QSR 820咨询服务
加拿大市场准入
培训服务
About Us
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Guangzhou Qimmiq Medical Consulting Service Co., Ltd. is a company specializing in providing technical, regulatory, and quality system consulting services for medical device products. Our company is committed to providing certification consulting for medical device quality systems and regulations such as ISO13485, CE, FDA, overseas product registration consulting, and professional knowledge training related to medical devices. We sincerely look forward to providing you with professional, satisfactory and efficient services. We will work with integrity, rigor, professionalism and enthusiasm, uphold the concept of 'achieving customers', provide comprehensive consulting services, and create higher value for your enterprise and your products.
Service Items
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US FDA Listing Registration
US FDA registration: 510 (k) application; Enterprise registration; Product listing; QMSR820 Quality System Establishment and Related System Training; FDA on-site flight inspection coaching; FDA Q-sub pre submission and other services.
EU Medical Device CE Certification
EU Medical Device CE Certification: CE certification services under the EU Medical Device MDR regulatory framework, including MDR technical document preparation, clinical evaluation report preparation, and related comprehensive quality system coaching and system training; Review and rectify non-conforming products.
MDSAPMedical Device Single Audit MDSAP
Consultation and coaching services for the MDSAP quality system of medical device single audit: responding to regulatory agencies in five countries (United States, Canada, Brazil, Japan, Australia)
Multi country compliant listing
Multi country compliance listing services:
a) UK Market Access (UKCA Certification)；
b) Canadian market access (MDL registration, MDEL registration)；
c) Brazilian market access services (ANVISA registration coaching, INMETRO certification coaching)
Service Process
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Requirement understanding
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Project initiation
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Assign team
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Report preparation
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Audit follow-up
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Certificate acquisition
Tel：020-82245821
E-mail：Jet.you@qimmiq-med.com
Add：Room 406, Building C, Runhui Technology Park, Shenzhou Road, Huangpu District, Guangzhou City, Guangdong Province
CopyRight @ Guangzhou Kuimei Medical Consulting Service Co., Ltd. All rights reserved 粤ICP备13022237号-1
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