Regulatory Documents and Submissions

Experienced in the Coordination, Writing, Review, and Approval 

of all your Regulatory Documentation Requirements. 

  • Facility Registration Assistance
  • Device Classification and Registration Assistance
  • 510(k) Application Preparation
  • Premarket Approval (PMA) Application Preparation
  • Investigational Device Exemptions (IDE) Preparation
  • CE Marking Consultation including Technical File Preparation
  • Warning Letter and Form 483 Response Assistance 
  • Coordination of other Regulatory Documentation for World-Wide Registration
  • Clinical Label Review and Approval