Sigmamed (Stock Code:873450) is a professional engaged in medical device registration and clinical research of innovative and comprehensive clinical research organizations, clinical research to provide one-stop service company covers business including medical devices clinical research, the third party inspection, equipment SMO, regulations, registration, production quality system services, biological statistics, data management, and other scientific research and service.We are committed to shortening the product launch cycle and saving R&D funds for customers, improving the quality control of clinical trials, and promoting the process of product marketization.
1. Clinical trials of class ⅱ and ⅲ medical devices and IVD(covering imported products)
2. Post-marketing research
3. Hospital-initiated clinical research
4. Epidemiological clinical studies
1. Comparison with varieties (equivalent equipment, comparable equipment)
2. Avoid clinical evaluation
1. Data management
2. Statistical analysis
3. EDC system
4. Random systems
5. Clinical trial management
1. Interpretation of regulations
2. Product research and development planning
3, the whole registration consultation and guidance
4. Write registration materials
5. Review the full set of registration information
6. Follow up the registration and obtain the product registration certificate
1. Preparation before inspection
2. Start the inspection
3. On-site inspection
4. Summary of inspection
5. Follow up
1. Medical strategy
2. Medical writing
3. Medical supervision
4. Third-party SMO services
