ERTRIAGE operates under a certified Quality Management System compliant with ISO 13485, the internationally recognized standard for medical device quality management.

This certification confirms that ERTRIAGE develops, maintains, and supports its clinical technologies under a structured, audited, and continuously monitored quality framework designed specifically for medical devices.

Quality is not an afterthought.
It is engineered into every stage of development.

What ISO 13485 Means for ERTRIAGE

ISO 13485 certification demonstrates that ERTRIAGE maintains:

• Controlled design and development processes
• Structured risk management procedures
• Documented validation and verification protocols
• Clinical evaluation governance
• Post-market surveillance systems
• Corrective and preventive action (CAPA) processes
• Full product traceability and documentation control

This ensures our medical AI solutions meet the highest standards required in regulated healthcare environments.

Applied Across ERTRIAGE Clinical Technology

As a clinical decision-support platform, ERTRIAGE HYBRID AI is developed within an ISO 13485-certified framework, ensuring:

• Controlled AI model lifecycle management
• Clinical performance validation
• Software verification and validation testing
• Risk classification and mitigation processes
• Change control and release governance
• Regulatory documentation alignment

This provides hospitals and regulatory authorities with assurance that the system is developed under a compliant and auditable medical device quality structure.

Lifecycle Governance — From Concept to Post-Market

ISO 13485 certification ensures that ERTRIAGE maintains oversight across the entire product lifecycle:

• Concept and requirements definition
• Design and development controls
• Risk analysis and mitigation
• Verification and validation
• Regulatory submission and approval
• Deployment and monitoring
• Continuous improvement through post-market feedback

This lifecycle discipline is essential for safe and reliable medical AI deployment.

Built for Regulatory Environments

ISO 13485 is a foundational requirement for compliance with:

Regulation (EU) 2017/745

Operating under an ISO 13485-certified QMS ensures that ERTRIAGE aligns with the structural expectations of MDR-regulated medical device manufacturers.

It reinforces:

• Safety
• Performance
• Risk control
• Documentation integrity
• Regulatory readiness

Confidence for Hospitals and Partners

Healthcare institutions deploying ERTRIAGE benefit from:

• Independently audited quality systems
• Structured product lifecycle management
• Controlled software updates
• Risk-managed AI deployment
• Regulatory-aligned documentation

This provides institutional confidence in both safety and compliance.

Where It Applies

ISO 13485 certification governs:

• ERTRIAGE HYBRID AI (clinical medical device platform)
• Design and development processes
• Quality control systems
• Clinical validation governance

Non-medical modules (such as ERTRIAGE FLOW or ERTRIAGE HOME) remain outside medical device scope but are developed under structured internal quality processes aligned with enterprise standards.

Quality Without Compromise

ERTRIAGE combines:

• Advanced AI innovation
• Clinical expertise
• Regulatory alignment
• Certified medical device quality systems

"Certified. Controlled. Compliant.
Built for the future of AI in healthcare. "