Regulatory & Quality Roadmap
Zynova OncoAtlas is currently positioned as an AI-assisted oncology workflow and evidence navigation platform. Regulatory classification may vary by intended use, market, deployment model, and clinical claims.
Current Positioning
The product is designed to support clinical team workflows without replacing physician judgment.
- Clinical workflow support
- Evidence navigation
- Structured documentation
- Tumor board preparation
- Physician-in-the-loop model
Intended Use Boundaries
The following boundaries apply to institutional evaluation and pilot planning:
- Does not diagnose
- Does not prescribe treatment
- Does not replace licensed physicians
- Supports clinical review and documentation workflows
United States Readiness
Assessment themes for the US market — not statements of FDA approval or clearance.
- FDA Clinical Decision Support Software assessment
- SaMD classification review
- HIPAA-aligned deployment planning
- Human oversight and auditability
European Readiness
Assessment themes for European markets — not statements of CE certification or conformity.
- MDR / CE pathway assessment
- EU AI Act high-risk AI readiness evaluation
- GDPR-aligned data governance
- Human oversight, transparency, and risk management
Türkiye Readiness
Readiness framework for the Turkish market and hospital operating environments:
- KVKK-aligned data handling
- Hospital workflow deployment
- HBYS/HIS integration readiness
- Physician-supervised clinical use
Quality & Safety Principles
Principles prioritized across product development and institutional evaluation:
- Human-in-the-loop
- Source-grounded outputs
- Audit trail
- Version control
- Clinical validation roadmap
- Post-deployment monitoring
- Risk management
Disclaimer
Zynova OncoAtlas supports oncology workflow, evidence navigation, and clinical documentation. It does not diagnose, prescribe treatment, or replace licensed physicians.
This page describes Zynova OncoAtlas’ regulatory and quality roadmap. It does not represent regulatory clearance, certification, or approval in any jurisdiction.