Regulations

Regulatory & Quality Framework

Volumina is a virtual reality (VR) medical imaging platform designed using software engineering practices commonly associated with FDA Class II medical device development. The system has been developed with the intention of supporting a future FDA submission, and ongoing data acquisition and validation studies are being conducted to support regulatory readiness. Until FDA clearance is obtained, Volumina is intended for research and evaluation purposes and is not cleared for diagnostic use.

Imaging Standards

  • DICOM Image Import and Processing
  • DICOM Metadata Preservation
  • Support for Standard Medical Imaging Workflows

Software Quality Assurance

  • Automated Unit Testing
  • Automated Integration Testing
  • Continuous Regression Testing
  • Version Controlled Development Process
  • Documented Verification Procedures
  • Traceable Defect Resolution Workflow

Security & Privacy

  • HIPAA-Aligned Data Handling Practices
  • Role-Based Access Controls
  • Audit Logging Capabilities