OVERALL RATINGS
INSTALLS
4
SUPPORT
- Partner Supported
Key highlights of the appRisk management for medical device and in vitro diagnostic manufacturers; ISO 14971 hazard analysis and FMEA in Jira
Stop managing safety risks in spreadsheets
Manage safety characteristics, hazards, harms and safety risks as native Jira work items. Assess, control and trace risk alongside the requirements that control it.
Assess risk, four ways
Run hazard analysis, design FMEA, process FMEA and use-related risk assessment. Each method has its own fields, and every risk inherits its severity from the linked harm.
See risk and find gaps
Compare initial and residual risk heat maps and see which records need attention. Warnings identify missing controls, hazards and harms, failure modes and scoring justifications.
More details
Manage medical device and IVD risk directly in Jira with structured Risk Sheets, configurable risk models and complete traceability from hazard to control to verification. Link each risk directly to the design, process or safety controls that mitigate it and to the tests that verify control effectiveness. Automatically maintain a Risk Traceability Matrix that gives teams and auditors a clear, current view of risk evaluation, mitigation, verification and residual risk.
Resources
App documentation
Comprehensive set of documentation from the partner on how this app works
Privacy and Security
Privacy policy
Atlassian's privacy policy is not applicable to the use of this app. Please refer to the privacy policy provided by this app's partner.
Partner privacy policySecurity program
This app is not part of the Marketplace Bug Bounty program.
Integration permissions
Safety Risk for Jira integrates with your Atlassian app
Version information
Version 2.1.0•for Jira Cloud
- Release date
- Sep 17th 2026
- Summary
- Minor version update
- Details
- Minor version update
- Payment model
- Paid via Atlassian
- License type
- Commercial