TOP GLP-CERTIFIED PRECLINICAL CRO MEDGAEA
Provide Total Solutions for Your Medical Devices
(Expertise & Cost Efficiency & Accelerated Timelines)
We provide services including,
1. Project Management
• ISO 10993-1 Consultation
• Comprehensive Project Oversight
2. Chemical Analysis
• ISO 10993-17 / -18 Compliance
• Chemical characterization of medical devices
3. Biocompatibility Testing
• ISO 10993 series safety tests
• USP 88 biocompatibility tests of raw materials
4. Performance Evaluation
• Customized performance tests
5. Clinical Trial Support
• Clinical trial strategy
• Regulatory consultation and submission