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Bioana-Tender
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Multi-functional Dental Instrument
Recopad
Cardiovascular stent
Self-pap for Cervical Cancer Sampling
Pediatric Endotracheal Tube Holder
ZipE®
AEROSKIN
Transpedicular screw
INTERVERTEBRAL DISC
OCCLUSION DEVICE
STENTGRAFT
INTRAVENOUS CATHETER
Central Venous Cathether Protection System
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FDA Clearance/Approval
Get the perfect strategy for fast approval to market for both U.S. and Mexico.
Regulatory Strategy Development
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Quality System Procedures
Quality Management and Assurance
Establishment Registration and Device Listing
Design Controls 21 CFR 820.30
Design History File Documentation
Device Master Record Documentation
510(k) Application
UDI Requirements Compliance FDA-COFEPRIS Homologation
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