US Agent and EU Authorized Representative Services

If you operate outside the U.S., but wish to sell or distribute product in the US, you need a US Agent. If you operate in the US, but wish to sell or distribute product in the EU, you need an EU Authorized Representative.

US Agent and EU Representative Service

RQMIS will:

  • Assist FDA in communications with the your non-US establishment
  • Respond to questions concerning the your non-US establishment’s devices that are imported or offered for import into the U.S.
  • Assist FDA in scheduling inspections of the your non-US establishment
  • Assist with FDA inspections
  • Receive information or documents from the FDA on behalf of your non-US establishment in the absence of effective communication between the two entities

EU Authorized Representative

RQMIS will:

  • Assist with device registrations and listings as required
  • Be identified on device product labeling throughout Europe
  • Make available to Competent Authorities (Ministries of Health, etc) a current copy of the device Technical File(s) and/or CE Declaration of Conformity for inspection
  • Assist the manufacturer and its distributors with Incident and Field Safety Corrective Action (FSCA) reporting
  • Assist with Competent Authority or Notified Body inspections

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