Regulatory Affairs
Domestic&Import:
Technical Requirement Service
CFDA Registration Application
Quality Management Consulting（GMP/QSR 820/ISO 13485/GSP）
Export:
CE/FDA Registration
US&EU UDI Standards Consulting
JPN MHLW/ KOR MFDS/ CAN HC/ AUS TGA/ BRA ANVIS, etc. Overseas Registries.
Clinical Evaluation
Clinical Evaluation Consulting
Clinical Trial Design
Clinical Trial Exemptions Consulting
Clinical Trial Monitoring
Clinical Study Report Writring/Revising
Clinical Data Management/Statistical Analysis
Clinical Audit
Medical Device Test
Testing Technical Service& Rectification
Pre-testing Technical Service
Testing Technical& Rectification Service
Medical Device CMO
Medical Device Sample Trial Production
Registration Testing& Clinical Trial Sample Production
Batch Production
Inevstment& Incubation
Investment & Financing Service
Regulations & Standards Training
Serving as Agent in China
