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
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