Terms of Service

1. Agreement to Terms

By accessing or using Cruxi's services ("Service"), you agree to be bound by these Terms of Service ("Terms"). If you disagree with any part of these terms, then you may not access the Service.

These Terms apply to all visitors, users, and others who access or use the Service, including but not limited to our regulatory compliance platform, classification services, predicate assessment tools, workflow orchestration features, evidence planning capabilities, and consultant directory/marketplace.

2. Description of Service

Cruxi provides an AI-powered regulatory compliance platform designed to assist with FDA medical device regulatory processes. Our services include:

• Device Classification: AI-powered device classification and product code identification services to help determine appropriate FDA regulatory pathways
• Predicate Assessment: Substantial equivalence analysis and predicate device identification to support 510(k) submissions
• Regulatory Assessment: Comprehensive regulatory requirements analysis to identify applicable FDA regulations, standards, and guidance documents
• Workflow Orchestration: Systematic workflow tools for FDA eSTAR submission generation, including document drafting and organization
• Evidence Planning: Document and testing evidence requirements identification and planning tools
• Consultant Directory and Marketplace: A platform that facilitates connections between users and independent regulatory consultants (see Section 3 for important disclaimers)

IMPORTANT: Cruxi provides a software platform and AI-powered tools only. Cruxi does not provide regulatory, legal, medical, or professional advice. All outputs generated by our platform are informational and must be reviewed and validated by qualified regulatory professionals. Users are solely responsible for ensuring compliance with all applicable FDA regulations and obtaining appropriate professional advice.

We reserve the right to modify, suspend, or discontinue any part of the Service at any time with or without notice. We shall not be liable to you or any third party for any modification, suspension, or discontinuation of the Service.

3. Consultant Directory and Marketplace

3.1 Platform Provider Only

Cruxi operates a consultant directory and marketplace platform that facilitates connections between users seeking regulatory consulting services and independent regulatory consultants. CRUXI IS A PLATFORM PROVIDER ONLY. CRUXI DOES NOT PROVIDE CONSULTING SERVICES, AND CRUXI IS NOT A REGULATORY CONSULTING FIRM.

3.2 Independent Third Parties

All consultants listed in our directory or marketplace are INDEPENDENT THIRD PARTIES who are not employees, agents, representatives, or partners of Cruxi. Consultants operate as independent contractors or independent consulting firms. Cruxi has no employment, agency, partnership, joint venture, or any other business relationship with any consultant listed on our platform.

3.3 No Endorsement or Warranty

Cruxi does not endorse, recommend, warrant, or guarantee the qualifications, expertise, services, or work product of any consultant. The inclusion of a consultant in our directory or marketplace does not constitute an endorsement, recommendation, or warranty by Cruxi. Users are solely responsible for evaluating, selecting, and engaging consultants. Cruxi makes no representations or warranties regarding:

• The qualifications, credentials, or expertise of any consultant
• The quality, accuracy, or completeness of any consultant's services
• The outcome or results of any consultant's work
• The compliance of any consultant's services with applicable laws or regulations
• The professional liability insurance or other protections maintained by consultants

3.4 Direct Relationship

Any engagement, contract, or relationship between a user and a consultant is a DIRECT RELATIONSHIP between those parties. Cruxi is not a party to any such engagement or contract. Users and consultants are solely responsible for:

• Negotiating the terms of their engagement
• Executing any contracts or agreements
• Managing their working relationship
• Resolving any disputes between them
• Complying with all applicable laws and regulations

3.5 No Liability for Consultant Services

CRUXI SHALL NOT BE LIABLE FOR ANY ACTS, OMISSIONS, ERRORS, NEGLIGENCE, OR MISCONDUCT OF ANY CONSULTANT, OR FOR ANY DAMAGES, LOSSES, OR LIABILITIES ARISING FROM OR RELATED TO ANY CONSULTANT'S SERVICES, ADVICE, OR WORK PRODUCT. Users engage consultants at their own risk and are solely responsible for the consequences of any consultant's services.

3.6 Consultant Verification

While Cruxi may display verification badges, certifications, or other indicators on consultant profiles, such indicators are based on information provided by consultants or third-party sources. Cruxi does not independently verify all consultant credentials, and users should conduct their own due diligence before engaging any consultant.

3.7 Consultant Profile Content

Consultant profiles on the Platform may exist in two states:

• Unclaimed Provisional Profiles: Profiles that have been generated by Cruxi using AI-assisted analysis of publicly available information (such as LinkedIn profiles, company websites, public directories, and other publicly accessible sources). These profiles are marked as "pending verification" or "AI-assisted" and are provisional until claimed by the consultant. Cruxi makes reasonable efforts to ensure accuracy but does not guarantee the completeness or accuracy of information derived from public sources.
• Claimed Profiles: Profiles that have been claimed and verified by consultants themselves. Once a consultant claims their profile, they may update, correct, or provide additional information. Consultants are responsible for ensuring the accuracy of information they provide in their claimed profiles.

Cruxi reserves the right to review, edit, modify, or remove any consultant profile content at any time for any reason, including but not limited to accuracy, completeness, compliance with these Terms, or Platform policies. Cruxi is not responsible for any inaccurate, misleading, or false information in unclaimed provisional profiles derived from public sources, or in claimed profiles provided by consultants.

Consultants may claim their profiles, request corrections to unclaimed profiles, or request removal of their profiles by contacting Cruxi at support@cruxi.ai.

4. Hybrid Approach

Cruxi's platform is designed to support a "hybrid approach" to regulatory compliance, where users may combine Cruxi's AI-powered tools with independent regulatory consulting services. This section explains how this model works:

4.1 Cruxi's Role

Cruxi provides AI-powered software tools that assist users in:

• Generating draft regulatory submissions and documentation
• Performing device classification and predicate analysis
• Identifying regulatory requirements and evidence needs
• Organizing and structuring regulatory information

Users may use Cruxi's tools to generate approximately 80% of draft submission content, allowing them to accelerate their regulatory processes and reduce costs.

4.2 Independent Consultant Services

Users may separately engage independent regulatory consultants (found through our directory/marketplace or elsewhere) for:

• Reviewing and validating AI-generated content
• Providing strategic regulatory advice
• Assisting with FDA communications
• Handling complex or borderline regulatory cases

4.3 Separation of Services

CRUXI'S SERVICES AND CONSULTANT SERVICES ARE COMPLETELY SEPARATE. Cruxi does not provide consulting services, and consultants do not provide Cruxi's software services. Any engagement with a consultant is independent of a user's relationship with Cruxi. Users may use Cruxi's platform without engaging any consultant, and users may engage consultants without using Cruxi's platform.

4.4 No Integration or Coordination

Cruxi does not integrate, coordinate, or collaborate with consultants in providing services to users. While consultants may review content generated using Cruxi's platform, such review is performed by the consultant as an independent service provider, not as an agent or partner of Cruxi.

5. Regulatory Compliance Disclaimers

5.1 No Regulatory Advice

CRUXI DOES NOT PROVIDE REGULATORY, LEGAL, MEDICAL, OR PROFESSIONAL ADVICE. All content, classifications, assessments, recommendations, and outputs generated through Cruxi's platform are provided for INFORMATIONAL AND GUIDANCE PURPOSES ONLY. Cruxi's platform is a software tool designed to assist users in regulatory processes, but it does not replace professional regulatory consultation or FDA review.

5.2 User Responsibility for Validation

Users are SOLELY RESPONSIBLE for:

• Validating all regulatory decisions, classifications, and assessments with qualified regulatory professionals
• Ensuring compliance with all applicable FDA regulations, guidelines, and requirements
• Verifying the accuracy, completeness, and suitability of all information and outputs for their specific regulatory submission
• Obtaining appropriate regulatory approvals from the FDA or other regulatory authorities when required
• Maintaining confidentiality of sensitive regulatory information
• Using the platform in accordance with all applicable laws and regulations

5.3 No FDA Approval Guarantees

CRUXI MAKES NO REPRESENTATIONS OR WARRANTIES REGARDING:

• The accuracy, completeness, or suitability of any information provided through the platform for any particular regulatory submission or purpose
• Whether any device will receive FDA approval or clearance
• Whether any regulatory pathway or strategy will be successful
• The compliance of any submission with FDA requirements
• The outcome of any FDA review or decision

5.4 Professional Review Required

ALL GENERATED CONTENT, CLASSIFICATIONS, ASSESSMENTS, AND RECOMMENDATIONS MUST BE REVIEWED AND VALIDATED BY QUALIFIED REGULATORY PROFESSIONALS AND, WHERE APPLICABLE, THE FDA OR OTHER REGULATORY AUTHORITIES. Users assume all responsibility and risk for decisions made based on platform outputs.

5.5 Compliance with FDA Guidelines

Users agree to use Cruxi's services in strict accordance with FDA guidelines and all applicable federal, state, and local regulations. Users must not use the platform for any unlawful purpose or in any way that could damage, disable, or impair the platform.

6. User Accounts

3.1 Account Registration

To access certain features of the Service, you must register for an account. When you register, you agree to:

• Provide accurate, current, and complete information
• Maintain and promptly update your account information
• Maintain the security and confidentiality of your login credentials
• Accept responsibility for all activities that occur under your account
• Immediately notify us of any unauthorized use of your account

3.2 Account Restrictions

You must be at least 18 years old to use the Service. By registering, you represent and warrant that you meet this age requirement.

You may not use another person's account without permission. You may not create multiple accounts for the purpose of circumventing Service limitations or restrictions.

3.3 Account Termination

We reserve the right to suspend or terminate your account at any time for any reason, including but not limited to violation of these Terms, fraudulent or illegal activity, or extended periods of inactivity.

4. Privacy and Data Protection

4.1 Data Collection and Use

Your use of our Service is also governed by our Privacy Policy. Please review our Privacy Policy, which also governs the Site and informs users of our data collection practices.

4.2 Data Security

We implement commercially reasonable security measures to protect your data. However, no method of transmission over the Internet or electronic storage is 100% secure, and we cannot guarantee absolute security.

4.3 Data Ownership

You retain ownership of all content and documents you upload to the Service. By uploading content, you grant us a limited, non-exclusive license to process, analyze, and store your content solely for the purpose of providing the Service to you.

4.4 Data Retention

We will retain your data for as long as your account is active or as needed to provide you services. You may request deletion of your data at any time, subject to legal and contractual obligations.

4.5 Confidentiality

Cruxi will treat your user content, including device documentation, regulatory information, and all data you upload to the Service, as confidential. We will not disclose your confidential content to third parties except: (a) to service providers who are bound by similar duties of confidentiality, (b) where required by law or legal process, or (c) with your explicit consent (for example, when you choose to share content with a consultant through the Service).

This confidentiality obligation is in addition to the privacy protections described in our Privacy Policy. For additional confidentiality arrangements, including custom NDAs, please contact us at legal@cruxi.ai.

8. Acceptable Use Policy

5.1 Permitted Use

You may use the Service only for lawful purposes and in accordance with these Terms. You agree to use the Service only for its intended purpose of document processing, analysis, and knowledge management.

5.2 Prohibited Uses

You agree not to use the Service to:

• Upload, process, or transmit any content that is unlawful, harmful, threatening, abusive, harassing, defamatory, vulgar, obscene, or invasive of another's privacy
• Impersonate any person or entity or falsely state or misrepresent your affiliation with a person or entity
• Upload or transmit viruses, malware, or any other malicious code
• Interfere with or disrupt the Service or servers or networks connected to the Service
• Violate any applicable local, state, national, or international law
• Collect or store personal data about other users without their consent
• Use the Service for any form of automated data scraping or harvesting
• Reverse engineer, decompile, or disassemble any part of the Service
• Remove, alter, or obscure any proprietary notices on the Service
• Use the Service to develop a competing product or service

5.3 Content Standards

All content uploaded to the Service must comply with applicable laws and regulations. We reserve the right to remove any content that violates these Terms or that we find objectionable.

9. Intellectual Property Rights

6.1 Our Intellectual Property

The Service and its original content (excluding content provided by users), features, and functionality are and will remain the exclusive property of Cruxi, Inc. and its licensors. The Service is protected by copyright, trademark, and other laws of the United States and foreign countries. Our trademarks and trade dress may not be used in connection with any product or service without our prior written consent.

6.2 Your Content

You represent and warrant that you own or have the necessary rights to use and authorize us to use all content you upload to the Service. You retain all rights to your content, subject to the limited license granted to us in these Terms.

6.3 Feedback

If you provide us with any feedback, suggestions, or recommendations regarding the Service ("Feedback"), you grant us an unlimited, irrevocable, perpetual, free license to use such Feedback for any purpose without any obligation to you.

6.4 DMCA Compliance

We respect the intellectual property rights of others. If you believe that any content on our Service infringes your copyright, please contact our designated DMCA agent at: dmca@cruxi.ai

7. Payment Terms

7.1 Subscription Plans

Access to certain features of the Service requires a paid subscription. By subscribing to a paid plan, you agree to pay all fees associated with your selected plan.

7.2 Billing and Renewal

Subscription fees are billed in advance on a recurring basis (monthly or annually, depending on your plan). Your subscription will automatically renew at the end of each billing period unless you cancel it before the renewal date.

7.3 Price Changes

We reserve the right to modify our pricing at any time. We will provide you with at least 30 days' notice of any price increases. Your continued use of the Service after the price change constitutes your agreement to pay the modified amount.

7.4 Refund Policy

We offer a 30-day money-back guarantee for annual subscriptions. Monthly subscriptions are non-refundable except where required by law. To request a refund, contact our support team at support@cruxi.ai within 30 days of your initial purchase.

7.5 Payment Processing

Payment processing services are provided by third-party payment processors. By providing your payment information, you agree to the terms and privacy policies of our payment processors.

11. Termination

8.1 Termination by You

You may terminate your account at any time by:

• Accessing your account settings and following the account deletion process
• Contacting our support team at support@cruxi.ai

Upon termination, your right to use the Service will immediately cease. If you wish to terminate a paid subscription, you must do so before the next billing cycle to avoid being charged for the next period.

8.2 Termination by Us

We may terminate or suspend your account immediately, without prior notice or liability, for any reason, including without limitation if you breach these Terms.

8.3 Effect of Termination

Upon termination:

• Your access to the Service will be immediately revoked
• We may delete your account data after a reasonable retention period
• You remain liable for any fees incurred before termination
• All provisions of these Terms that should survive termination will remain in effect

9. Disclaimers and Limitations of Liability

9.1 Service Disclaimer

THE SERVICE IS PROVIDED ON AN "AS IS" AND "AS AVAILABLE" BASIS. CRUXI EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT.

9.2 No Guarantee of Accuracy

While we strive for accuracy, we make no warranty that:

• The Service will meet your specific requirements
• The Service will be uninterrupted, timely, secure, or error-free
• The results obtained from the Service will be accurate or reliable
• Any errors in the Service will be corrected

9.3 Limitation of Liability

IN NO EVENT SHALL CRUXI, ITS DIRECTORS, EMPLOYEES, PARTNERS, AGENTS, SUPPLIERS, OR AFFILIATES BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING WITHOUT LIMITATION, LOSS OF PROFITS, DATA, USE, GOODWILL, OR OTHER INTANGIBLE LOSSES, RESULTING FROM YOUR USE OF THE SERVICE.

9.4 Maximum Liability

IN NO EVENT SHALL OUR TOTAL LIABILITY TO YOU FOR ALL DAMAGES, LOSSES, AND CAUSES OF ACTION EXCEED THE AMOUNT YOU HAVE PAID US IN THE LAST TWELVE (12) MONTHS, OR ONE HUNDRED DOLLARS ($100), WHICHEVER IS GREATER.

13. Indemnification

You agree to defend, indemnify, and hold harmless Cruxi, Inc., its affiliates, licensors, and service providers, and its and their respective officers, directors, employees, contractors, agents, licensors, suppliers, successors, and assigns from and against any claims, liabilities, damages, judgments, awards, losses, costs, expenses, or fees (including reasonable attorneys' fees) arising out of or relating to:

• Your violation of these Terms
• Your use of the Service, including any data or content transmitted or received by you
• Your violation of any third-party right, including any copyright, property, or privacy right
• Any claim that your content caused damage to a third party
• Your violation of any applicable laws, rules, or regulations
• Any FDA actions, rejections, RTAs, or regulatory issues arising from your use of the Service
• Any regulatory submissions, classifications, or assessments made based on Service outputs
• Any engagement with or services provided by any consultant, regardless of whether such consultant was found through Cruxi's platform
• Any failure to obtain appropriate professional review or validation of Service outputs

We reserve the right, at our own cost, to assume the exclusive defense and control of any matter otherwise subject to indemnification by you, in which event you will fully cooperate with us in asserting any available defenses.

11. Governing Law and Dispute Resolution

11.1 Governing Law

These Terms shall be governed and construed in accordance with the laws of the State of New York, United States, without regard to its conflict of law provisions. Our failure to enforce any right or provision of these Terms will not be considered a waiver of those rights.

11.2 Arbitration Agreement

Any dispute arising out of or relating to these Terms or the Service shall be resolved through binding arbitration in accordance with the rules of the American Arbitration Association. The arbitration shall be conducted in New York, New York, and judgment on the award may be entered in any court having jurisdiction.

11.3 Class Action Waiver

YOU AGREE THAT ANY DISPUTE RESOLUTION PROCEEDINGS WILL BE CONDUCTED ONLY ON AN INDIVIDUAL BASIS AND NOT IN A CLASS, CONSOLIDATED, OR REPRESENTATIVE ACTION. You waive your right to participate in a class action lawsuit or class-wide arbitration.

11.4 Exceptions

Notwithstanding the above, either party may seek injunctive or other equitable relief in any court of competent jurisdiction to prevent the actual or threatened infringement, misappropriation, or violation of a party's copyrights, trademarks, trade secrets, patents, or other intellectual property rights.

11.5 Time Limitation

You agree that regardless of any statute or law to the contrary, any claim or cause of action arising out of or related to use of the Service or these Terms must be filed within one (1) year after such claim or cause of action arose or be forever barred.

15. Contact Information