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Terms of Service for PrediClear LLC

Effective Date: May 2, 2026

1. AI-Generated Content & Transparency Disclosure

In accordance with 2026 New Jersey AI Transparency regulations (SB 3668), users are hereby notified that the data, technical specifications, and publication summaries provided through this platform are compiled, organized, and generated by autonomous artificial intelligence systems. While these systems are overseen by human professionals, the primary processing of large-scale datasets is automated.

2. Descriptive Data Only (Regulatory Scope)

This platform serves as a Regulatory Intelligence Tool. The services provided are strictly limited to the compilation of descriptive, publicly available technical information and peer-reviewed publications.

  • This tool does not provide medical advice, diagnoses, or clinical recommendations.
  • This tool does not predict FDA or regulatory outcomes.
  • The output is intended for use by qualified engineering and regulatory professionals as a research aid and not as a substitute for independent professional judgment.

3. Data Accuracy & "Human-in-the-Loop" Verification

While PrediClear LLC employs "Human-in-the-Loop" (HITL) verification protocols, the nature of AI-driven compilation means that errors or omissions may occur.

User Responsibility: Users must verify all technical specifications and regulatory citations against official sources (FDA, PubMed, ISO) before making business, safety, or regulatory decisions.

4. Technical Compliance (FDA QMSR / ISO 13485:2016)

PrediClear LLC is architected to align with the FDA Quality Management System Regulation (QMSR) and ISO 13485:2016. Use of this tool does not constitute a full Quality Management System (QMS).

5. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY NEW JERSEY LAW, THE TOTAL LIABILITY OF PREDICLEAR LLC FOR ANY CLAIMS UNDER THESE TERMS, INCLUDING FOR ANY IMPLIED WARRANTIES, IS LIMITED TO THE AMOUNT YOU PAID US TO USE THE SERVICES IN THE PAST TWELVE MONTHS, OR $1,000.00, WHICHEVER IS LESS.

6. Governing Law & Venue

These terms are governed by the laws of the State of New Jersey. Any disputes shall be resolved exclusively in the state or federal courts located in New Jersey.

7. Intellectual Property

The unique arrangement, metadata tagging, and searchable architecture of this database are the proprietary trade secrets of PrediClear LLC. Bulk scraping or unauthorized reproduction is strictly prohibited.

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PrediClear LLC provides a decision-support tool for regulatory research. We do not provide legal, clinical, or regulatory advice. All AI-generated outputs require verification by a qualified professional.
© 2026 PrediClear LLC. AI-powered regulatory intelligence for medical devices.