Regulatory Affairs Services

Libra Medical's extensive experience allows us to provide a comprehensive, global regulatory strategy for all classes of medical devices, IVD, and Biologics. The regulatory affairs strategy is seamlessly integrated into the clinical research and quality assurance strategy for a smooth execution of the program.

Services provided:

  • Regulatory Affairs strategic planning including obtaining approval to market the product.
  • Review and assessment of  existing regulatory affairs strategies.
  • Consultation to the engineering team for the regulatory affairs and product standards requirements.
  • Represent the client in interaction with the Regulatory Agencies (pre-IDE and pre-submission meetings).

 

  • Product submissions to the FDA (510(k), PMA, IDE, HDE).
  • Panel Meeting.
  • Product submission to Health Canada, EU, Australia and Japan
  • Device registration in other international countries.
  • Regulatory due diligence.
  • Device Listing and Establishment registration.
  • MDR and Vigilance reporting.