Ketryx for Physical AI
Physical AI compliance, built for scale.
Meet IEC 61508, ISO 9001, and other functional safety and quality standards for physical AI applications, spanning robots, self-driving vehicles, safety-critical devices, and smart factories.
Physical AI products face unique compliance complexity
Traceability breaks at the system boundary.
Tracing requirements from system-level safety goals through embedded software, AI model behavior, and physical test results requires toolchain-spanning visibility. Spreadsheets and manual trace matrices cannot maintain consistency across these boundaries.
Risk analysis cannot keep pace with AI iteration.
Autonomous systems introduce novel hazards that change with every model update. Manual risk processes cannot keep pace with iterative AI development cycles.
Change impact cascades across the full stack.
When an AI model retrains or a sensor specification changes, the impact ripples through firmware, safety logic, and regulatory documentation. Without automated impact analysis, teams trace changes by hand and still miss dependencies.
How Ketryx can help
Ketryx simplifies document control, training management, non-conformance reporting, and complaint handling, seamlessly integrating with your team’s existing tools like Jira, GitHub, and AWS. By unifying all actions in a single system, Ketryx ensures traceability, accountability, and audit readiness, helping you pass internal and external audits. Minimal complexity. Maximum compliance.
Traceability
Maintain digital knowledge continuity with self-tracing compliance software
Track requirements from system-level safety goals through embedded software, AI model behavior, and physical test results across every tool in your stack.
Full component visibility in real-time requirements traceability matrix
Bidirectional traceability spanning hardware and software boundaries
Gap detection and coverage analysis across regulatory frameworks
Documentation
Automate documentation across domains
Generate submission-ready documentation as engineers build, across mechanical, firmware, software, and AI/ML domains.
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Reduce manual copy-paste errors across disconnected toolchains
Developers focus on building, not retroactive documentation
Streamline technical file generation for multi-domain products
Risk Management
Streamline risk management for autonomous systems
Map risk controls to design inputs and test results automatically. Maintain a living risk file that updates as your product evolves.
AI-assisted preliminary hazard analysis for autonomous behavior-compliant.
Automated risk control traceability from FMEA to verification
Continuous risk monitoring across AI model retraining cycles
Enforcement
Enforce SOPs with engineering controls
Implement configurable controls aligned with applicable standards such as IEC 61508, ISO 13849-1, ISO 26262, and IEC 62304 to ensure compliance with functional safety, software lifecycle, and QMS regulatory requirements across domains.
Risks have corresponding controls mapped automatically
Built-in frameworks enforce best practices across release gates
Robust validation and verification processes for Physical AI
Development Tools
Rapidly accelerate AI compliance in development and deployment, while monitoring model drift
Use your preferred AI/ML tools so you can get to market faster.
Attract and retain machine learning specialists, who can work in their preferred tools
Connect model drift analysis and ML testing frameworks and leverage them as evidence against your requirements
Automatically create traceability between requirements in Jira and tests in Git (or another code repository)
AI Assistant
Deploy the Ketryx Assistant for quality review
Ketryx automates routine compliance tasks with Ketryx's Assistant and AI agents but keeps your team in control of critical decisions.
Run the Ketryx Assistant to scan across your connected systems to find the things humans miss and suggest improvements
Ketryx Agents perform risk-based quality review, test coverage analysis, and conflict detection across your entire artifact chain
Maintain human-in-the-loop review on AI suggestions, traceability links, and enforcement rules.
Design Controls
Generate design controls from source code
Whether you follow the V-model top-down, generate controls from existing code, or produce region-specific documentation, Ketryx supports your workflow.
Manage design inputs, design outputs, user needs, and verification activities with full traceability across connected systems
Generate design controls from source code. Ketryx AI Agents scan your codebase to extract design outputs, test links, and risk controls, turning weeks of manual work into minutes
Produce region-specific documents from the same design controls. Label items for EU, US, or both, and generate compliant documents for FDA or EU MDR
How a Fortune 50 Robotics Company Moved 80% Faster
A Fortune 50 Robotics company partnered with Ketryx to accelerate releases and modernize risk management workflows. Improvements to its Cybersecurity System Architecture (CSA) exposed gaps in a process slowed by fragmented tools, inconsistent data, and manual handoffs. Ketryx unified these processes into an AI-driven system that streamlined prioritization and increased review throughput. The result: the team now operates 80% faster.