[Skip to main content](https://www.ketryx.com/capabilities/risk-management#) [](https://www.ketryx.com/capabilities/risk-management#) This is some text inside of a div block. 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](https://docs.ketryx.com/manuals/man-08-risk-management#id-8.-release-documents) ### **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](https://docs.ketryx.com/reference/project-settings#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](https://www.ketryx.com/blog/the-ultimate-guide-to-requirements-traceability-matrix-rtm) ### **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](https://www.ketryx.com/blog/21-cfr-part-11-compliance-guide-for-jira-atlassian) ### **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](https://www.ketryx.com/learn/webinars/register/postmarket-surveillance-of-ai-systems-proactive-methods-for-identifying-risk-and-improving-product-quality) ### **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](https://www.ketryx.com/capabilities/enforcement) Are You Building Medical Software? ## Get started building software in minutes, not months. [Book a demo](https://www.ketryx.com/schedule-demo) .png)