The EU deadline for conformance to the new MDR is May 26, 2020. Is your company ready?
RQMIS

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

Success Story

FDA Inspection of a Combination Product Manufacturing Facility

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

Success Story

EN/ISO13485 Certification for a Chinese Manufacturer

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