Medical Device Requirements Management Software
Manage and trace requirements across systems with ease
Duplicating requirements across systems creates rework and wastes engineering time.
Without a connected way to manage requirements, teams copy-paste from Jira or Git into an eQMS or ALM — burning developer time and increasing attrition risk.
Connected Requirements Management
FDA-grade requirements management software, wherever you work
Create your requirements in Jira or the tool of your choice. Get full visibility and traceability across both Jira and Ketryx.
Trace requirements from Jira, source code, ALM, or PLM
- Use the pre-configured issue type “Requirement” in Jira to create new requirements with ease
- Trace requirements and see them progress as their issue status changes
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Establish links between requirements
- Set parent requirements in Jira as design inputs
- Trace requirements to specifications, tests, and any new risk items that emerge
Draft, query, and validate requirements with AI
- Use Ketryx AI to draft requirements, test cases, and specifications from a prompt
- Ask plain-language questions about your requirements in seconds: what's missing, what conflicts, what's untested
- Automatically detect conflicting or duplicate requirements and get suggested resolutions, before they cause downstream rework
- Every AI-generated item is human reviewed and approved through a Part 11-compliant workflow, so nothing enters your DHF without expert approval
Manage requirements without leaving your AI tools
- With the Ketryx MCP (Model Context Protocol), query and create requirements directly from Claude, ChatGPT, or any MCP-compatible AI coding environment
- Ask your AI coding assistant to surface relevant requirements, check traceability gaps, or draft new items, all grounded in your live Ketryx project data
- Keep developers in their preferred tools while maintaining the full compliance and traceability your QMS requires
See requirements traceability in real time
- Automatically maintain a real-time requirements traceability matrix across all connected systems so it’s always up to date — no manual work required
- See and resolve coverage gaps across systems at a glance
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Create documentation automatically
- Generate artifacts directly from requirements, like your change management file, risk control matrix, risk management file, risk matrix, SRS, SDS, test plan, and traceability matrix
- Automatically produce fully configurable submission-ready documentation at the end of each development cycle
Control closed requirements
- Automatically move the Requirement to a Closed state after all approval rules have been passed (all required groups have approved the Requirement)
- Automatically add a comment to the Jira issue with a link to the effective controlled record in Ketryx
Streamline change management
- See a detailed record of what changes were made, when they were made, and who made them
- Automate your Part 11-compliant audit trail
- Get context for why certain changes were made with audit-ready documentation
Configure custom approval rules
- Configure approval rules and groups to match your workflows and SOPs
- Include the item assignee (author of the requirement), product managers, R&D leads, and quality managers in your approval groups as needed
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