See it in action
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Stop manually scoring every complaint. SaMD Complaint Risk Assessment runs a structured ISO 14971-aligned risk assessment directly on your Jira ticket — defect classification, probability, severity, and a final risk score — in under a minute.
Free. Requires an Anthropic API key and Jira Cloud.
Every complaint that comes in needs to be triaged. Is it a defect? What's the risk? Does it need a CAPA? For small quality teams, that process is manual, time-consuming, and inconsistent.
Determines whether the issue represents a deviation from a User Need or Product Requirement. NON-DEFECTs are flagged immediately.
Scores the likelihood that users encounter this defect during normal use, using your configured 1–5 scale.
Scores the potential harm if the defect occurs — grounded in patient safety and therapeutic impact, not just software severity.
Combines probability and severity against your configured 5×5 risk matrix to produce a risk level and recommended disposition.
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See a real complaint triaged from start to finish — defect classification, risk scoring, and the auto-posted summary comment.
Video walkthrough coming soon
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Your product requirements, user needs, probability scale, severity scale, and risk matrix are all defined in the Settings panel. Nothing is hardcoded.
Every conclusion comes with citations — the specific comments or fields that influenced the classification. Audit-ready by design.
No context switching. The panel runs directly on the issue. Results can be auto-posted as a formatted comment on the ticket.
The four-step pipeline maps directly to the risk management process required for SaMD under ISO 14971.
You bring your own Anthropic API key. Issue content is sent to the Claude API for processing and is not stored by this app.
No license fees. Install from the Atlassian Marketplace and run assessments for the cost of a few Anthropic API tokens per ticket.
It's not a replacement for a qualified engineer's judgment. It's the first pass — consistent, documented, and fast — so your team can focus on the decisions that actually need human review.
Cahill Consulting Group LLC works with SaMD companies on quality management, risk frameworks, and regulatory strategy. If your team needs hands-on support — not just software — let's talk.
cullom@cahillconsultinggroup.com
Install from the Atlassian Marketplace, enter your Anthropic API key in Settings, and run your first assessment.
Get it free on Atlassian Marketplace →Privacy note: Issue content (title, description, comments) is sent to Anthropic's API for processing. This app does not store issue content after the API call completes. Your configuration data (product requirements, risk matrix, etc.) is stored in Atlassian Forge Storage. See our Privacy Policy and Terms of Service.