Regulatory Affairs & Registration
The GCP regulatory affairs & registration team for medical device was originated from the Technical Regulations Department of China Association for Medical Devices Industry (CAMDI). The head of the department has rich pra
Able to undertake medical device registration and post-marketing clinical trials. Have extensive project management experience and expert resources in various therapeutic areas such as ophthalmology, cardiothoracic surgery, v
Clinical Evaluation Report (CER)
Services include: project strategy consultation, clinical evaluation feasibility assessment and consultation; selection and differential analysis of the similar medical devices; comprehensive literature search in database for
Data Management and Statistical Analysis
Dimeisi, founded in 2003, is one of the first data statistics teams in China. The data center consists of the biometrics department, data management department and program department, undertaking projects at home and abroad.