Our Methodology
Built for regulatory compliance, not just speed. Understand how Veridocx delivers defensible, FDA-grounded analyses.
Scientific & Regulatory Foundation
Medical device submissions require more than language models. Our methodology combines deterministic validation, semantic retrieval, and expert-aligned reasoning.
Deterministic Validation
Classification rules derived directly from FDA guidances. No hallucinations on regulatory requirements.
Complete Traceability
Every recommendation includes FDA citations, confidence scores, and reasoning chains. Full audit trails.
Always Current
Weekly synchronization with FDA 510(k) database and regulatory updates. Grounded in precedent.
Technical Approach
Advanced computational methods, agentic systems, and graph database architectures powering regulatory-grade accuracy and traceability.
Advanced Computational Methods
Our computational engine leverages sophisticated rule-based systems and agentic architectures to process FDA regulations and guidance. Powered by deterministic computational methods, we ensure regulatory-grade accuracy without compromise.
- Agentic systems that navigate complex regulatory frameworks
- Computational methods validated against FDA standards
- Intelligent decision pathways for classification accuracy
Graph Database & Knowledge Systems
Our graph database architecture enables sophisticated relationship mapping across 180,000+ cleared submissions. Advanced computational methods identify predicate devices through multi-dimensional analysis of device characteristics, indications, and regulatory networks.
- Graph-based knowledge systems mapping regulatory relationships
- Multi-dimensional similarity analysis using computational methods
- Regulatory network traversal for comprehensive predicate discovery
Agentic Documentation & Audit Systems
Our agentic systems automatically generate comprehensive documentation with complete traceability. Computational methods ensure every output includes full audit trails, source citations, and regulatory-grade justification for seamless integration into your submission workflow.
- Agentic systems that construct complete audit trails automatically
- Computational methods ensuring FDA source traceability on every output
- Intelligent documentation generation ready for regulatory review
Detailed technical documentation is in preparation. Contact us for early access to methodology documentation.
Ready to see it in action?
Experience regulatory-grade 510(k) preparation with complete audit trails.