The FDA requires all foreign firms wishing to market medical products in the USA to appoint a US agent. Accordingly, we have established MedicSense USA, a Boston-based subsidiary that enables us to provide our clients with:

  • U.S. Agent activities.
  • Establishment Registration and Medical Device Listing.
  • FDA-related compliance services, including IDE, 510(k) and PMA submissions.
  • Direct liaison with the FDA.