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.