Committed to creating bridges between
Medical Device Manufacturers and Markets

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Dr. Zafirios Gourgouliatos
Regulatory Specialist
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John Lyon
International Marketing Strategy and Distribution
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Glen Mizelle
Senior Marketing Executive
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Our Services

  • FDA Registration
  • California FDB
    Registration
  • Risk Management
    (plan and execution)
  • 510(k) Submission
    (Pre-Market Notification)
  • Quality System Compliance
        Quality System Part 820
        Templates for small and
        large companies
        Quality System Implementation
        Quality System Audits
  • Crisis Management
        483 Responses
        Warning Letter Response
        Recall Assistance
  • Medical Device
    Safety Testing
  • Technical File
  • Pre-IDE Consulting
  • IDE (Investigational Device Exemption)
  • PMA
    (Pre-Market Approval)
  • Human Factor Study and Performance Testing
  • United States Agent/Official Correspondent Services
  • ISO Registration, CE Marking
  • DMEPOS Accreditation
  • DME/HCPCS Code
    Application
    HIPAA Compliance
  • Health Canada
    Registration
  • EU Representation

  

  

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