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Group Introduction
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Testing
Quality system
CDMO
Regulatory consulting
·Seeding·
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Regulatory survey
Strategic planning for global market access
PredicatedEquivelent / Predicated device survey
Contract service of scientific research
Transformation of scientific research results
CMO/CDMO
Quality System Consulting
Risk Management
Medical Device Software Validation
Process Design and Development / Design tranfer
Design Verification / Validation Planning
Biological Evaluation
Preclinical Animal Study
Reprocessing Validation
Product Performance Testing Registration Testing
Human Factor / Usability Evaluation
Microbiological Tests
Cybersecurity Test
Package Verification and Shelf Life Verification
Electrical Safety Testing
EMC Tests
Clinical Evaluation
Regulations and Standards Training
Application of Medical Device NMPA Registration
U.S. Premarket Notification [510(k)] Submission
U.S. PMA / De Novo Classification
CE Marking and UKCA consulting
Russia and CIS Registration Consulting
Canada Medical Device License Application
Brazil ANVISA Registration
Quality System Inspection Support
Local representative service
Post-market clinical follow-up
Adverse event handling
Recall service
Regulatory research and product change planning
Registration / certification changes
Product market withdraw services
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