Relying on the support of professional teams in China, integrating the over 20 years’ CFDA working experience and the start-up company consulting experience of the core team, we focus on providing the regulation affairs related consulting services of medical devices in China and overseas.
We would like to provide a one-set service for medical device companies, which is the product registration oriented, with the quality system construction as the core and the clinical researches as the support.
The one-set service is consisting of:
- Strategy designing for medical device registration
- Products’ definition and classification
- Registration documents’ compilation and instruction(composing technical specification of products included)
- Sample delivery and tests
- Clinical experiments for products‘ registration
- Communication with the product technical review team (Center for Medical Device Evaluation, CMDE)
We provide first-class service with reasonable price. The charge rate varies according to the product and item.