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AI Driven Risk Management

ISO 14971-compliant medical device risk management software

 

Risk management is vital to build FDA-grade medical software, but error-prone manual processes leave gaps in the traceability and documentation of risks.

Managing risks effectively can be a daunting task with the constant need to ensure comprehensive documentation, adhere to regulatory standards, and track risk controls. Without a robust system in place, teams struggle with incomplete documentation, overlooked risks, and unverified controls, leading to potential compliance issues and product release delays.

Automated Risk Management

Control and document every risk automatically with risk management tools

Ensure comprehensive risk control

Guarantee complete documentation of all risks and controls compliant with ISO 14971 and prevent product releases with unverified tests of risk controls (IEC 62304).

  • Automatically document risks and see unverified risk controls before product release
  • Easily review all risks and instantly see the associated risk controls to ensure that no gaps exist
  • Get AI-suggested failure modes based on your product type and regulatory standards, reducing initial risk assessment time
Learn more about risk documentation

Reduce FDA and EU MDR compliance risk

Product releases are gated by verification and validation tests of risk controls (IEC 62304).

  • Gate product releases until all risks are documented, tested, and approved
  • Ensure that all necessary risk controls are in place before the product reaches the market
  • Identify missing test cases and verification gaps automatically with AI analysis of your DHF, reducing V&V preparation time
Explore release controls

Save time on traceability

Save time by easily navigating across all traced items in any system with a comprehensive traceability matrix.

  • Link every risk to its corresponding controls, requirements, and specifications through automated traceability
  • Navigate and manage complex risk relationships with ease through an always up-to-date trace matrix
  • Swap weeks of manual trace matrix creation with real-time automated connections from risks to controls to tests to verification evidence
Read The Ultimate Guide to Requirements Traceability Matrix

Ensure QMS compliance

Ensures SOPs are followed in any connected system in the correct order.

  • Embed Standard Operating Procedures (SOPs) into all connected tools (like Jira and GitHub) so you maintain compliance across all systems
  • Ensure that every risk is managed and documented according to industry standards with built-in guardrails
  • See which requirements are risk controls directly in Jira and GitHub with visual indicators, preventing accidental removal during development
See how Ketryx enforces your SOPs in Jira

Recapture time to focus on high-risk items

By focusing on high-risk items, you can allocate resources more effectively and ensure that all significant risks are properly controlled.

  • Automate low value, time intensive activities to make time for critical activities
  • Easily identify and manage the most critical risks with robust filtering capabilities
  • Identify which risks are affected by code changes in minutes with AI-assisted impact analysis, reducing post-market update cycles from weeks to days
Watch webinar: Identifying Risks in AI Systems

Give risks and risk controls equivalent priority

  • Focus your energy on the most important risks and risk controls by quickly seeing critical risks
  • Eliminate unnecessary work by ensuring that development efforts are focused on only those Risk Controls that mitigate the risk identified
  • Ensure that Risk Controls adequately address Risks and are properly traced
  • Flag unacceptable residual risk automatically in real-time before production, enabling proactive mitigation instead of reactive compliance checks
Explore engineering controls

Check Risk Status from Any AI Tool

The Ketryx MCP Server exposes your knowledge graph through the Model Context Protocol standard, so AI tools your team already uses can query the graph directly. Engineers check risk coverage, identify traceability gaps, and verify control effectiveness without leaving their preferred AI tool.

  • Ask "Are there any unverified risk controls blocking this release?" in Claude, or ChatGPT
  • Detect traceability gaps between hazards, controls, and verification evidence from any MCP-compatible AI tool
  • Reduce time spent reviewing your risk file from weeks to hours so you can release when your development team is done
Learn more about Ketryx MCP
From Concept to Post-Market

AI-Powered Risk Management Across Every Development PhaseSpecialized AI Agents for
High-Impact Compliance Work

Risk management doesn't stop at initial identification. It evolves throughout your product's entire lifecycle. Ketryx AI works across the TPLC, from accelerating early FMEAs to integrating post-market surveillance data.
Accelerate Risk Identification
Identify and Protect Risk Controls
Complete Risk Control Verification
Systematic Field Evidence Integration

Accelerate Risk Identification

Create comprehensive FMEAs faster with AI-generated first drafts. AI Assistant suggests failure modes based on your product type and regulatory standards, so SMEs can refine rather than starting from scratch, reducing bottlenecks and enabling earlier design decisions.

Identify and Protect Risk Controls

Know what's already controlling risk and what could. Ketryx flags existing risk controls in your requirements and design so developers don't accidentally remove them, while the AI Assistant analyzes your DHF to suggest potential new risk controls based on your design and regulatory standards.
Learn More

Complete Risk Control Verification

AI Agents identify gaps where test cases are missing. They also surface existing tests, documentation, and evidence that can verify control effectiveness. Automated traceability connects everything, while release gates prevent shipping unverified controls.
Learn More

Systematic Field Evidence Integration

Turn post-market surveillance into systematic risk management updates. AI Assistant analyzes field complaints to identify affected risks and controls, suggests whether existing mitigations remain adequate, and shows exactly which documentation needs updating. Automated traceability and version control maintain regulatory audit trails throughout.