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Tel: 0086 571 87206574
Email: [email protected]
Consulting
Pre-market
QMS(Quality Management System)
Training and Other Consulting Services
Entrusted R&D and production services
Medical Device R&D Support
Master Files Submission
Master Files Submission of Raw Materials in China
Master Files Submission of Pharmaceutical Excipients in China
Master Files Submission of Pharmaceutical Packaging Materials in China
Technical Support for R&D
Medical Device Registration
Product Classification
Medical Device Filing/Recording and Registration
Class I Medical Device Filing/Recording
Class II/III Medical Device Initial Registration
Class II/III Medical Device Registration Change
Technical Files Compilation
Testing
Other Services
Clinical Evaluation & Clinical Trial
Clinical Evaluation (Non-trial Method)
Clinical Evaluation Report for Products that are Exempt from Clinical Trials
Clinical Evaluation Report for Adopting Clinical Trials or Clinical Application Data of the Same Variety Products
Clinical Evaluation Report for Adopting Overseas Clinical Trials Data
Clinical Evaluation Report for Adopting Real-world Data
Clinical Trial
Pre-clinical Animal Experiment
Medical Device Safety Evaluation and Testing
Chemical Characterization of Materials
Safety Evaluation for Extractables & Leachable Substances
Biocompatibility Testing
Microbiological Testing
Validation of Cleaning,Disinfection, Sterilization
Restricted Substance Testing
Cleaning Room Environment Validation and Process Water Testing
Regulatory News
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