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