Terms of Service

1. Acceptance of Terms

By installing or using the SaMD Complaint Risk Assessment app ("the App"), you agree to be bound by these Terms of Service. The App is provided by Cahill Consulting Group LLC ("we," "us," or "our"). If you do not agree to these terms, do not install or use the App.

2. Description of the App

The App is a free Jira Cloud application that uses AI (via Anthropic's Claude API) to perform structured risk assessments on Jira issues, designed to assist medical device quality teams in complaint triage. The App is intended as a decision-support tool, not a replacement for qualified engineering or regulatory judgment.

3. Use of Third-Party AI Services

The App transmits Jira issue content to Anthropic's API for AI processing. By using the App, you acknowledge that:

• You are responsible for obtaining and maintaining your own Anthropic API key
• Your use of Anthropic's services is subject to Anthropic's usage policies and privacy policy
• Costs incurred through your Anthropic API key are your responsibility
• You have the authority to send your organization's Jira issue content to a third-party AI service

4. Not a Regulatory or Medical Device

The App is a software productivity tool. It is not a medical device, a quality management system, or a validated regulatory compliance tool. AI-generated risk assessments produced by the App:

• Are not a substitute for the judgment of a qualified engineer, regulatory professional, or quality manager
• Should be reviewed and validated by a competent person before use in any regulated process
• Do not constitute compliance with ISO 14971, FDA 21 CFR Part 820, EU MDR, or any other regulatory requirement

You are solely responsible for determining whether and how to use the App's outputs in your quality management processes.

5. Free Use and No Warranty

The App is provided free of charge. It is provided "as is", without warranty of any kind, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, or non-infringement.

We do not warrant that the App will be uninterrupted, error-free, or that AI-generated assessments will be accurate, complete, or suitable for any particular purpose.

6. Limitation of Liability

To the fullest extent permitted by applicable law, Cahill Consulting Group LLC shall not be liable for any indirect, incidental, special, consequential, or punitive damages arising out of or related to your use of the App, including but not limited to decisions made based on AI-generated risk assessments.

Our total liability to you for any claims arising from use of the App shall not exceed $0, as the App is provided at no charge.

7. Data and Privacy

Your use of the App is also governed by our Privacy Policy, which is incorporated into these Terms by reference.

8. Atlassian Marketplace Terms

The App is distributed through the Atlassian Marketplace. Your installation and use of the App is also subject to the Atlassian Marketplace Terms of Use.

9. Changes to the App or Terms

We reserve the right to modify or discontinue the App at any time without notice. We may also update these Terms of Service; the "Last updated" date at the top of this page indicates when changes were last made. Continued use of the App after any changes constitutes acceptance of the revised Terms.

10. Governing Law

These Terms shall be governed by and construed in accordance with the laws of the United States, without regard to conflict of law principles.

11. Contact

For questions about these Terms, contact:

Cahill Consulting Group LLC
cullom@cahillconsultinggroup.com
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