We serve you internationally. Our strategic locations in the US and China help bridge the gap between the FDA and your factory.

IRC and its partners can handle any of your Medical Device regulatory needs. We have created partnerships with testing labs to ensure your testing is completed satisfactory and meets the critical needs demanded by the FDA.

IRC’s FDA Medical Device Compliance Service:

  • FDA Establishment Registration
  • FDA Owner/Operator Registaration
  • FDA Importer/Initial Distributor Registration
  • FDA Medical Device Listing (MDL)
  • FDA US Agent Registraion
  • FDA Official Correspondent
  • FDA 510(k) /PMN
  • FDA GMP Establishment Inspection Support
  • Software validation
  • Device Classification
  • FDA GMP: QSR820 Compliance Servcie
  • Test Support
  • Clinical Trial Support
  • Training and Seminars
  • MORE…