Libra Medical’s extensive experience allows us to provide a comprehensive, global regulatory strategy for all classes of medical devices, IVD, and Biologics.

Regulatory Services Offered

Premarket Notification (510k).

Premarket Approval Application (PMA).

Investigational Device Exemption (IDE).

Humanitarian Device (HUD).

Master files.

Humanitarian Device Exemption (HDE).

Registration and licensing.

Preparation and representation at FDA advisory panels and regulatory agency meetings.

Import certificates and registration.

Investigational New Drug (IND).

New Drug Application (NDA).

Biologic Licensing Application (BLA).

Product submission to Health Canada, EU, Australia and Japan.

Device registration in other international countries.

Device Listing and Establishment registration.

MDR and Vigilance reporting.