FDC Services, LLC
International Clinical/Regulatory Affairs
Compliance & Quality Systems
Services We Provide
FDC Services Include:

  • US and International Medical Device Clinical and Regulatory Affairs; including clinical
    plans, protocols, 510(k)'s, PMA's, and IDE's.  Submission assistance  for Canada,
    Australia, Brazil, Japan, Korea, Taiwan, China, and Europe.
  • FDA Liaison; FDA pre-submission strategy meetings, Panel and Committee
    meetings, Official Correspondent, US Agent Services
  • Regulatory, QSR, and cGMP Compliance; Compliance Audits, Training, Management
    Assistance
  • Recall and Field Action Activities; Public Affairs, Health Hazard Evaluation, FDA
    notification requirements, Remedial Actions, Management of Recall tracking and
    notifications.
  • Complaint, MDR, and Vigilance Reporting Systems; Training and Department Set-up
  • Quality Systems; ISO 13485 and QSR Compliant Quality Systems, Quality Manuals,
    Internal Audit, CAPA
  • CE Marking, Technical Files, Design Dossiers; Work with European Notified Bodies
    and Competent Authorities, Declarations of Conformity, Risk Analysis, Essential
    Requirements, Clinical Summaries
  • Clinical Affairs; Site Initiations, Clinical Monitoring, Protocol Development
  • Due Diligence; New Business Development and Acquisition Evaluations.  Potential
    Business Partner and Supplier Audits
  • Sterilization Technology and Validation Services, Including Aseptic Fill Technology,
    Ethylene Oxide, Steam, Dry Heat, Ozone, Sterrad, and Radiation
  • Clean Room and Lab Design
  • CGMP and Medical Device Regulatory Training
  • Representation at Technical Committees and Industry Associations

FDC Services is affiliated with several other quality consulting firms so if we can't help
you, we probably know someone who can.  Please contact us for assistance.