Terms of Service

Acceptance of Terms

By accessing or using Claripulse (“the Service”), you agree to be bound by these Terms of Service. If you do not agree to these terms, do not use the Service. If you are using the Service on behalf of an organization, you represent that you have the authority to bind that organization to these terms.

Service Description

Claripulse is a research and informational tool that analyzes publicly available FDA MAUDE (Manufacturer and User Facility Device Experience) adverse event data. The Service detects statistical anomalies in adverse event reporting patterns and surfaces them through a web-based dashboard for use by medical device professionals.

Medical and Regulatory Disclaimer

Claripulse is not a medical device, diagnostic tool, or clinical decision support system. The Service does not provide medical advice, diagnosis, or treatment recommendations.

Signal detection results are statistical indicators derived from voluntarily submitted adverse event reports. They do not represent confirmed safety findings, nor do they establish a causal relationship between a device and an adverse event.

Claripulse is not a substitute for formal FDA post-market surveillance programs, complaint handling systems, or regulatory compliance processes. Users are solely responsible for their own regulatory obligations and should consult qualified professionals and FDA guidance as appropriate.

Data Accuracy

MAUDE reports are submitted voluntarily by manufacturers, healthcare facilities, and consumers. They may contain incomplete, inaccurate, or unverified information. Reporting rates vary by device type, reporter, and time period. An increase in reports does not necessarily indicate an increase in adverse events. We make reasonable efforts to process this data accurately, but we do not warrant the completeness, correctness, or timeliness of any information presented through the Service.

Account Responsibilities

You are responsible for maintaining the confidentiality of your account credentials and for all activity that occurs under your account. You agree to provide accurate and current information when creating your account and to notify us promptly of any unauthorized use.

Acceptable Use

You agree that you will not:

• Attempt to re-identify any individuals from the de-identified MAUDE data presented in the Service.
• Use the Service to make clinical decisions about individual patient care.
• Circumvent, disable, or interfere with any security features of the Service.
• Use automated means (bots, scrapers, crawlers) to access the Service without our written permission.
• Access or attempt to access another user's account.
• Use the Service for any purpose that violates applicable law.

You may use Claripulse data for research, regulatory, quality improvement, and internal business purposes in accordance with applicable laws.

Intellectual Property

The underlying FDA MAUDE data is in the public domain. The Claripulse service, including its signal detection algorithms, analysis methods, user interface, branding, and original content, is the intellectual property of Claripulse and is protected by applicable copyright and trademark laws.

We grant you a limited, non-exclusive, non-transferable, revocable license to use the Service for its intended purpose. You may not copy, modify, distribute, or reverse-engineer any part of the Service.

You retain ownership of any data you provide to Claripulse, such as watchlist selections and account information.

Limitation of Liability

To the maximum extent permitted by law, Claripulse and its officers, employees, and affiliates shall not be liable for any indirect, incidental, special, consequential, or punitive damages arising from your use of or inability to use the Service. This includes, without limitation, damages arising from decisions made based on data or analysis presented through the Service.

Our total aggregate liability for all claims arising from or related to the Service shall not exceed the amount you paid us in the twelve months preceding the claim, or $100, whichever is greater.

Warranty Disclaimer

The Service is provided “as is” and “as available” without warranties of any kind, whether 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 free of harmful components.

Indemnification

You agree to indemnify, defend, and hold harmless Claripulse and its officers, employees, and affiliates from any claims, damages, losses, or expenses (including reasonable attorneys' fees) arising from your use of the Service, your violation of these Terms, or your violation of any third-party rights.

Termination

You may stop using the Service and delete your account at any time. We may suspend or terminate your access if you violate these Terms or if we discontinue the Service. Upon termination, your right to use the Service ceases immediately. Provisions that by their nature should survive termination (including limitation of liability, indemnification, and governing law) will remain in effect.

Changes to These Terms

We may update these Terms from time to time. If we make material changes, we will notify you by email or by posting a notice on our website at least 30 days before the changes take effect. Your continued use of the Service after the effective date constitutes acceptance of the revised Terms.

Governing Law

These Terms are governed by the laws of the United States and the state in which Claripulse is principally operated, without regard to conflict-of-law provisions. Any disputes arising from these Terms or your use of the Service shall be resolved in the applicable state or federal courts, and you consent to the personal jurisdiction of those courts.

Contact Us

If you have questions about these Terms, contact us at admin @ claripulse.com.