September 26, 2018

FANG CONSULTING CLINICAL AFFAIRS

Fang Consulting’s Clinical Affairs consulting services include:

  • Clinical Device & Case Support
    • Field Clinical Specialist
    • Site Study Support
  • Clinical Evaluation Reports (CERs)
    • Development of new CERs
    • Update existing CERs
    • Compliant with MedDev 2.7.1 Rev. 4
    • Compliant with EU MDR 2017/745 Requirements
    • Literature Reviews
    • Post-market Surveillance and Vigilance Reviews
  • Clinical Study/Trial Site Monitoring
    • Site Initiation
    • Site Qualification
    • Interim Monitoring
    • Event Reporting
    • Close-out Visits
    • Annual and Final Report Writing
  • Clinical Trials that support FDA Submissions
    • IDE
    • 510(k)
    • de Novo
    • PMA

Expertise Provided

  • Standard Operating Procedure (SOP) Development
  • Clinical Project Management, Site Training, Case Study Support, Site Monitoring
  • Clinical Evaluation Report (CER) and Clinical Study Report (CSR) Development, and Annual Report Writing
  • Summary of Safety and Clinical Performance Development and Updates
  • Medical Device Training