RQMIS
Doing or planning to do business outside of the US? Visit our sister companies. RQMIS AR LTD. or RQMIS EU SL More

US Agent and EU Authorized Representative (AR)

If you're looking to sell or distribute your product in the US, but your company operates outside of it, you need a US Agent!

Alternatively, if you're looking to sell or distribute your product in the EU, but your company operates outside of those territories, you need an EU Authorized Representative (AR)!

Let Us Be Your US Agent

RQMIS will:

  • Assist FDA in communications with your non-US establishment
  • Respond to questions concerning your non-US establishment’s devices that are imported or offered for import into the U.S.
  • Assist FDA in scheduling inspections of 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

Success Story

FDA Inspection of a Combination Product Manufacturing Facility

Or Your EU Authorized Representative (AR)!

RQMIS will:

  • Assist with device registrations and listings
  • 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

Success Story

EN/ISO13485 Certification for a Chinese Manufacturer

Ready to get started?

We’ll drop you a line and start a conversation. Just put in your email. We won’t spam you.