50% Faster Regulatory Submissions for Medical Device Firms
When HSA or FDA requests additional technical documentation for a Class II device, delays cost months of market access. Oxaide ensures instant retrieval of design history files, test reports, and regulatory correspondence.
100%
Data Sovereignty
Isolated
Memory Architecture
24/7
Operational Triage
Ideal Deployment Profile
The Challenge
Design History Files (DHFs) scattered across engineering, QA, and regulatory teams
FDA/HSA queries require days of cross-departmental coordination
Patient data and clinical trial information requires strict isolation
Audit preparation consumes entire quarters of regulatory team time
The Solution Architecture
Architecture Step 1
Sovereign RAG indexes all technical documentation, test reports, and regulatory submissions
Architecture Step 2
Air-gapped option for patient data and clinical trial documents
Architecture Step 3
Automated retrieval of design verification and validation records
Architecture Step 4
Role-based access for cross-functional regulatory response
Deployment Outcomes
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