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.