Quality and Regulatory Compliance

Quality and Regulatory Compliance

Get the perfect strategy for fast approval to market for both U.S. and Mexico.

Regulatory Strategy Development
Tailored Quality System Design (FDA GMP)
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