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PRIVACY
POLICY:
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
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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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