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3335 Tuscarawas Rd
Beaver, PA 15009

+1 412 418 8066

info@qaraconsultinggroup.com

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Contact us today to learn how QA/RA Consulting Group can assist you.

Regulatory Affairs

QA/RA Consulting Group offers extensive industry experience regarding:

  • Regulatory Strategies (Devices / Drugs / Biologics)
  • Global Medical Device Approval and Registration (ROW)
  • FDA Warning Letter / 483 Support
  • PMA Submissions / 510(k) Notifications
  • Sterilization Tech File Support
  • Device Registration and Listing
  • FDA Consent Decree Support
  • CE Marking / European MDD Compliance
  • Tech Files / Design Dossiers
  • CMDR Compliance and Licensing
  • Complaint Management / Adverse Event Reporting
  • U.S. Designated Agent for Foreign Manufacturers
  • Post Launch Regulatory Support
  • Master File Preparation and Maintenance

U.S. Agent Services

This registration requirement applies to the following categories of foreign establishments:

  • Primary Manufacturers

  • Contract Manufacturers and Remanufacturers

  • Contract Sterilizers

  • Foreign Exporter of devices located in a foreign country

  • Specification Developers/Reprocessors of single use devices

Contact us today to learn more about how QA/RA Consulting Group can assist you.

Services include:

  • Assist FDA in communication with the foreign manufacturer/ establishment.

  • Respond to questions from the FDA regarding the foreign establishment’s devices that are offered for import into the US.

  • Assist FDA in scheduling inspections of the foreign manufacturer.

  • Reporting adverse events (under 21 CFR 803 Medical Device Reporting (MDR) regulations) 

  • Initial Registration of a new Establishment via the on-line FDA Unified Registration and Listing System (FURLS).

  • Facilitate processing of Client’s payment of the FDA Establishment Registration Fee (annual requirement)

  • Initial Listing of medical devices that will be imported into and marketed in the US.

  • Update the on-line Registration and Listing records annually as required by FDA and as needed.

  • Provide an importation letter template, as requested, to facilitate importation.

  • Provide notifications and updates from the FDA regarding changes to the Registration and Listing requirements.