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Leilux, Inc. is committed to keep confidential all information provided by customers and safeguard such information when working with subcontractors.


Leilux, Inc. is HIPAA compliant and very sensitive to the privacy of Personal Health Information (PHI). Member of the group and subcontractors are receiving HIPAA training before working in projects that may give them access to Personal Health Information.


Before sharing any confidential information, please compete, sign, and send us an electronic copy of an NDA followed by the original in the mail. Use the form below or you can use the forms of your company.


Leilux Inc Standard Non Disclosure Agreement - PDF
(click her for file)


Leilux Inc Standard Non Disclosure Agreement - MS-Word
(click her for file)


We will sign, scan, and send us an electronic copy followed by the original in the mail. We will not accept any


Our Services

  • FDA Registration
  • California FDB
  • 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
    HIPAA Compliance
  • Health Canada
  • EU Representation



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