KunTuo

Home > Integrated services for Medical Device and Diagnostic (MDD) companies

Integrated services for Medical Device and Diagnostic (MDD) companies

Medical DeviceKun Tuo has a professional, dedicated MDD team for Medical Device and diagnostic (MDD)s and serves as Quintiles’ MDD service delivery arm in China. Our MDD team has been trained by Quintiles and Novella on Medical Device and diagnostic (MDD)s and diagnostic reagents.

Kun Tuo’s regulatory affairs team is well-versed in Chinese Medical Device and diagnostics (MDD) regulations. We focus on Medical Device and diagnostics projects with a wealth of experience in cardiovascular stents, peripheral stents, orthopedic, ophthalmology, oral, neurosurgery, trauma surgery, Oncology, medical cosmetology, diagnostic reagents and test equipment. We also have robust experience in long-term cooperation with customer. Our Medical Device and diagnostics (MDD) unit can offer you full-spectrum, one-stop clinical research services.

Our integrated services for Medical Device and diagnostic (MDD) companies
  • Medical Device and diagnostic (MDD) Regulatory affairs services
    1. Product initial registration, re-registration, change of registration
    2. Product technical requirement/standard preparation
    3. regulatory and R&D strategy consulting
  • Clinical evaluation report (CER) development 
  • Medical Device and in vitro diagnostic reagents: clinical study design, e.g. randomized, blinded and controlled
  • Sample size estimation, selection of statistical methods, statistical reporting
  • Product/sample testing
  • Clinical trials (Lead Principal Investigator selection, site selection, EC submission, contracts negotiation, site initiation, site monitoring, site close-out)
  • Clinical safety management
  • Data management and statistics
  • Clinical study report writing
  • Medical writing
  • Medical translation

Medical Device