Free app
OVERALL RATINGS
INSTALLS
2
SUPPORT
- Partner Supported
Key highlights of the appAI-powered complaint triage for medical device quality teams ISO 14971-aligned risk scoring in Jira
Structured risk assessment in one click
Runs defect classification, probability scoring, severity scoring, and final risk level. All in under a minute, directly on your Jira issue.
Knows when it's not a defect
Not every complaint needs a CAPA. SaMD Risk Assessment identifies non-defects with clear rationale so your team can close tickets faster with confidence.
Fully configurable to your product
Set your own User Needs, Product Requirements, probability and severity scales, and risk matrix. Every assessment is tailored to your specific product context.
Supporting media
More details
Designed specifically for Software as a Medical Device (SaMD) quality and regulatory teams. Configurable to your product, set your own User Needs, Product Requirements, probability/severity scales, and risk matrix. Assessment results can be auto-posted as a Jira comment for traceability. Runs entirely on Atlassian Forge. Issue content is sent to Anthropic's API for processing and is not stored by this app.
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
SaMD Complaint Risk Assessment integrates with your Atlassian app
Version information
Version 2.1.0•for Jira Cloud
- Release date
- Apr 20th 2026
- Summary
- Privacy & Security updates
- Details
Privacy and Security questionnaire updates. Added DPA. Minor improvements.
- Payment model
- Free
- License type
- Commercial - no charge