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International Regulatory Consultants

7151 South 700 West, Suite 105
Salt Lake City, UT 84047-7101 USA
Tel: +1 801 233 0075
Fax: +1 801 233 0089

Web: http://www.irclc.com
E-mail: dfgrabarz@irclc.com


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U.S. DESIGNATED AGENT
and
OFFICIAL CORRESPONDENT

A Trademark Service Of

What We Do:

  • Annual FDA Registration & Device Listing
  • Regulatory Services
  • Coordination with US Importer/Distributor
  • Medical Device Reporting/Complaint Handling
  • US cGMP & Regulatory Systems Analysis/Auditing
  • Clinical Research (CRO)
  • Quality Systems Services
  • US FDA On-site Inspection Coordination
  • 510(k) Submissions/Premarket Approval Applications
  • IDE Submissions & Clinical Trial Management
  • Strategic and Regulatory Planning
  • Training and Education Services
  • Personnel Training

    How We Work:

    IRC offers a variety of fee-based Option Plans to fit each manufacturers budget and needs, which are proven to be highly cost-effective based on the size of the company and the product volume and criticality. We are your mandatory voice in representing you to the U.S. Food and Drug Administration. U.S. Agent/Official Correspondent Services allow IRC to demonstrate our value to your business.

    IRC Strategic Alliance Partners

  • Korea Testing Laboratories
  • Visamed GmbH for EU Authorized Representative
  • MediMark for EU Authorized Representative
  • Vector Resources for U.S. Marketing Logistics
  • MedLink Europe for European Marketing Logistics

    Together with IRC a Strong Team for Success

    European Authorized Representative

    VISAMED GmbH, located in Karlsruhe, Germany, is a European-based consultancy which provides a full range of services to medical device and in vitro diagnostic manufactures. As a strategic alliance partner of IRC, VISAMED offers its services as European Authorized Representative in accordance with those requirements under European Medical Device Directives and the In Vitro Device Directive. For details contact IRC

    MediMark® Europe headquartered in Grenoble, France and administrative offices in Flemington, New Jersey, is a strategic alliance partner of IRC and enhances services to both existing and new clients with compliance requirements under the present European Medical Device Directives and the In Vitro Device Directive. For details contact IRC.


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