Welcome to MedReg Consulting, LLC

​MedReg Consulting, LLC specializes in mapping and implementing
​regulatory and clinical strategy for medical device
​development, design change, and continued compliance.
​MedReg is intent on providing decisive strategic guidance and tactical service to
​best suit the client’s business objectives.

Key Regulatory Experience​

• ISO 13485 Compliance
• Quality System Regulation
• Design Controls
• Device Classification
• Due Diligence Audits 
• FDA Submissions
  • FDA Q-Submissions
  • 510(k) Submissions
  • PMA Submissions
  • 10.75 Appeals for Formal Dispute Resolution
• CE Mark Technical Files
• MDR & IVDR Compliance
• Global Registrations
• In vitro diagnostics (IVDs)
• Combination Products 
• Medical Device Software & AI
• System Integration
• Risk Management
• Laboratory Developed Tests
• CLIA Lab Certification, Compliance, Licensure, and Survey Support ​

Click here to contact MedReg Consulting now.