CLASS THREE, LLC

Medical Device Regulatory Consulting

Specializing in higher risk and novel devices:

  • Class I and II De Novo

  • Class III Premarket Approval

  • Class 2 and 3 EU Design Dossiers

  • Device classification

  • Regulatory path assessment

  • FDA pre-submission meetings

  • IDE applications

  • De novo requests

  • EU design dossiers

  • EU technical files (MDD/MDR)

  • EU clinical evaluation reports

  • Cardiovascular

  • Orthopedic

  • General and Plastic Surgery

  • Obstetric and Gynecological

  • Opthalmic

  • Dental

  • Diagnostics/LDTs