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
.png)
Establish links between requirements
- Set parent requirements in Jira as design inputs
- Trace requirements to specifications, tests, and any new risk items that emerge
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
.png)
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
.png)
.png)