We primarily provide quality regulatory consulting services to domestic and international medical device enterprises, including product rectification, registration strategy consulting, innovation applications, QMS coaching, registration submissions, post-market support, and other services throughout the entire lifecycle of product. Committed to accelerating the research and development process of medical devices, our team consists of experts who are proficient in medical device regulatory registration, quality management systems for medical devices, and sterile medical device sterilization packaging technology. We have led and successfully passed inspections and audits by major global regulatory authorities (such as NMPA, FDA, KFDA, Brazil, etc.) and third-party certification bodies multiple times, possessing extensive experience.
Regulatory Affairs - Regulatory Consultation
Interpretation of regulations and policies
Registration strategy planning
Product classification definition
QMS registration questions answered
Testing consultation
Registration/filing documentation review
Regulatory Affairs - Domestic medical device registration
Class I listing/change listing
First registration of Class II/III
Renew registration of Class ll/lll
Class II/III change filing
Class II/III change registration
Clinical trial approval
Instruction manual changes
Medical device certificate Reissuance/Correction/Cancellation
Other green channel applications, such as innovation application, priority approval, emergency approval, etc.
Regulatory Affairs - Overseas medical device registration
EU CE Certification (MDR)
FDA registration (Listing, 510K, PMA)
Japan PMDA registration
Canadian HC registration
Australian TGA registration
Quality Managemet system
ISO13485:2016 Quality System Consulting
China Quality System Consulting
NMPA Registrant MAH Consulting
GSP Quality System Consulting
FDA QSR820 Inspection and 483 Report Consulting
Medical Device Single Audit Program（MDSAP）Consulting
Other Customized Quality System Consulting and Training
Design and development process control
Risk management
Process validation
Sterilization process validation and routine control (ISO1137, ISO11135)
Medical device package system evaluation (including packaging process validation)
Utility System Validation
Laboratory consulting services (microbiological test training, cleanrooms test, ethylene oxide residue test, testing equipment validation, etc.)
Cleanrooms and laboratory design consulting
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