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.

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