Committed to creating bridges between
Medical Device Manufacturers and Markets

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