Our services

Regulatory Affairs Consulting

Humanitarian Device Exemption (HDE) Pre-Market

  • HUD Designation Application Review
  • Comparable Legally Marketed Device Statement Review
  • Device Description Review
  • Risk Assessment Review
  • Clinical Data Review
  • Non-clinical Data Review
  • Quality System Information Review
  • Labeling Proposal Review
  • FDA Form 3674 Review

Our brands and projects