Committed to creating bridges between
Medical Device Manufacturers and Markets

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DISCLOSURE:

 

Leilux, Inc. is a C corporation operating under the laws of the United States and the State of California.

 

Leilux, Inc. does not have registrations with the FDA, ISO, or other authority but it applies business practices that are compliant with the requirements or regulating bodies, state, national, and international laws. The company applies the generally accepted accounting principles (GAAP)s in project budgeting, billing, and invoicing.

 

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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