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SERVICE ITEMS
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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
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