Quality First International

REGULATORY ASSURANCE

QFI provides skilled guidance and direct assistance to clients during Notified Body, Competent Authority and US FDA audits. We have an exemplary record in this capacity.

To date, no QFI-implemented Quality Management System has ever failed initial assessment or given rise to a non-compliance report (483 under US FDA 21 CFR).

To date, no technical submission prepared by QFI Technical Specialists has ever been refused clearance.

regulatory assurance