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Leilux,
Inc. was incorporated in 2008 by a group of professionals in the Medical
Device Industry to provide services in:
The
company has provided expertise to a number of mature and
start-up medical device companies.
DeThurst
A
new smart device - details to be announced.
www.dethrust.com
Ritenim™
A
new smart device - details to be announced.
www.ritenim.com
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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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