OVERALL RATINGS
INSTALLS
3
SUPPORT
- Partner Supported
TRUST SIGNALS
Key highlights of the appRisk management for Life Sciences; ISO 14971 hazard analysis and FMEA in Jira
Your risk register, natively in Jira
One risk register per space holds safety characteristics, hazards, harms and risk sheets, native Jira items. Each risk sheet links to the requirements that control it. A risk control is a requirement in Design Control.
Customizable risk model, matched to your procedure
The risk model follows the risk management procedure you already have approved: the probability bands, the severity scale the harms carry, the matrix that turns those into a risk level, and the acceptability criteria.
Risk Traceability Matrix with gap analysis
The Risk Traceability Matrix shows every risk against the requirements controlling it, and how far each control has been implemented and verified. Warnings count the gaps: risks with no risk control, no hazard or harm.
More details
About Qity
An eQMS that runs natively in Jira, built by medtech industry adepts. Break silos between QARA, engineering and manufacturing teams, so quality management is no longer spread over fragmented documents and emails. Automatically produce quality records from DevOps.
Safety Risk for Jira, part of the Qity eQMS suite. Risk sheets in Jira, directly linked to the risk controls that mitigate them and the tests that verify them. One register covers hazard analysis, design FMEA, process FMEA and use error.
Each risk control is a requirement, so Design Control carries its implementation and verification. A Risk Traceability Matrix flags the gaps.
Automated installation qualification (IQ) built in. Supports ISO 14971, ISO 13485, EU MDR, IVDR and 21 CFR Part 820. Approvals carry 21 CFR Part 11 e-signatures.
Docs or book a demo.
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 2.2.0•for Jira Cloud
- Release date
- Oct 13th 2026
- Summary
- Minor version update
- Details
Minor version update
- Payment model
- Paid via Atlassian
- License type
- Commercial