Terms of Service

1. Acceptance of Terms

By accessing or using DeviceWatch ("the Service"), operated by DeviceWatch ("we," "our," or "us"), you agree to be bound by these Terms of Service. If you do not agree to these terms, you may not use the Service. These terms apply to all users, including individual users and users acting on behalf of an organization.

2. Description of Service

DeviceWatch is a software-as-a-service (SaaS) platform that monitors the FDA MAUDE database for medical device adverse event reports and provides AI-powered analysis, trend detection, and compliance-ready reporting.

3. Important Disclaimers

Not a Medical Device

DeviceWatch is not a medical device and is not intended to be used as one. The Service is a software tool for information management and analysis only. It is not intended to diagnose, treat, cure, or prevent any disease or medical condition, and it does not make clinical or regulatory decisions.

AI-Generated Content

DeviceWatch uses artificial intelligence (Claude by Anthropic) to analyze and summarize FDA adverse event reports. All AI-generated content, including summaries, trend analyses, failure mode classifications, and severity assessments, is provided for informational purposes only. AI-generated content may contain errors, omissions, or inaccuracies.

Users must have qualified professionals review all AI-generated summaries and analyses before incorporating them into compliance documentation, regulatory submissions, or any decision-making process.

FDA Data Limitations

DeviceWatch sources data from the publicly available FDA MAUDE database via the openFDA API. The FDA MAUDE database has inherent limitations, including but not limited to: incomplete reporting, reporting delays, unverified causal relationships, duplicate entries, and data entry errors. We make no warranty regarding the completeness, accuracy, or timeliness of the underlying FDA data.

4. Subscription and Billing

• Free Trial — All new accounts receive a 14-day free trial with full access to the features of your selected plan. No credit card is required to start a trial.
• Billing Cycle — Subscriptions are billed monthly on the anniversary of your subscription start date. Charges are non-refundable except as required by applicable law.
• Cancellation — You may cancel your subscription at any time from your account settings. Upon cancellation, you will retain access to the Service until the end of your current billing period. No partial refunds are provided for unused portions of a billing period.
• Price Changes — We may change subscription prices with 30 days' advance notice. Continued use of the Service after a price change constitutes acceptance of the new pricing.

5. User Responsibilities

As a user of DeviceWatch, you agree to:

• Maintain the security of your account credentials and not share login information with unauthorized individuals
• Provide accurate information when configuring product codes and device monitoring settings
• Ensure that qualified regulatory and quality professionals review AI-generated content before use in compliance activities
• Use the Service in compliance with all applicable laws and regulations
• Notify us promptly of any unauthorized access to your account
• Not attempt to reverse-engineer, decompile, or disassemble any portion of the Service
• Not use the Service to compete directly with DeviceWatch or to build a similar product

6. Intellectual Property

Our Property

The DeviceWatch platform, including its software, design, algorithms, documentation, and branding, is owned by DeviceWatch and protected by intellectual property laws. Your subscription grants you a limited, non-exclusive, non-transferable license to use the Service for its intended purpose.

Your Data

You retain ownership of all data you provide to the Service, including your account information, product code configurations, review notes, and any other content you create within the platform. We do not claim ownership of your data. You grant us a limited license to process your data solely to provide the Service.

7. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, DEVICEWATCH AND ITS OFFICERS, DIRECTORS, EMPLOYEES, AND AGENTS SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS, DATA, USE, OR GOODWILL, ARISING OUT OF OR IN CONNECTION WITH YOUR USE OF THE SERVICE.

OUR TOTAL AGGREGATE LIABILITY FOR ALL CLAIMS ARISING OUT OF OR RELATING TO THESE TERMS OR THE SERVICE SHALL NOT EXCEED THE AMOUNT YOU PAID US IN THE TWELVE (12) MONTHS PRECEDING THE EVENT GIVING RISE TO THE CLAIM.

WITHOUT LIMITING THE FOREGOING, DEVICEWATCH SHALL NOT BE LIABLE FOR ANY DAMAGES ARISING FROM: (A) RELIANCE ON AI-GENERATED CONTENT WITHOUT REVIEW BY QUALIFIED PROFESSIONALS; (B) INCOMPLETENESS OR INACCURACIES IN FDA MAUDE DATA; (C) REGULATORY DECISIONS MADE BASED ON INFORMATION PROVIDED BY THE SERVICE; OR (D) UNAUTHORIZED ACCESS TO YOUR ACCOUNT DUE TO YOUR FAILURE TO MAINTAIN ACCOUNT SECURITY.

8. Warranty Disclaimer

THE SERVICE IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. WE DO NOT WARRANT THAT THE SERVICE WILL BE UNINTERRUPTED, ERROR-FREE, OR COMPLETELY SECURE.

9. Indemnification

You agree to indemnify, defend, and hold harmless DeviceWatch and its officers, directors, employees, and agents from and against any claims, liabilities, damages, losses, and expenses (including reasonable attorneys' fees) arising out of or in any way connected with: (a) your use of the Service; (b) your violation of these Terms; or (c) your violation of any applicable law or regulation.

10. Termination

We may suspend or terminate your access to the Service at any time for violation of these Terms or for any other reason at our sole discretion, with or without notice. Upon termination, your right to use the Service will immediately cease. You may request an export of your data within 30 days of termination by contacting us.

11. Changes to Terms

We reserve the right to modify these Terms at any time. We will provide notice of material changes by posting the updated Terms on this page and updating the "Last updated" date. Your continued use of the Service after changes constitutes acceptance of the revised Terms.

12. Governing Law

These Terms shall be governed by and construed in accordance with the laws of the State of Delaware, United States, without regard to its conflict of law provisions. Any disputes arising out of or relating to these Terms or the Service shall be subject to the exclusive jurisdiction of the state and federal courts located in the State of Delaware.

13. Severability

If any provision of these Terms is found to be unenforceable or invalid, that provision shall be limited or eliminated to the minimum extent necessary so that these Terms shall otherwise remain in full force and effect.

14. Contact Us

If you have any questions about these Terms of Service, please contact us at:

support@devicewatch.app