Last updated: Feb 9, 2026
These Terms of Use (“Terms”) govern your access to and use of the Reginabox website and services, including regulatory documentation templates and related materials (the “Services”). By accessing or using this website, you agree to these Terms.
If you do not agree with these Terms, you should not use this website or Services.
1. Company Information
This website is operated by h2o Therapeutics ( “we,” “us,” or “our”).
Reginabox provides regulatory documentation templates and related resources intended to support digital health and Software as a Medical Device (SaMD) teams.
2. Nature of Services
Reginabox provides:
- Documentation templates
- Guidance materials
- General regulatory information
- Consulting services (if separately agreed)
All templates and materials are provided as general resources only.
Reginabox does not provide legal advice, regulatory approval, or certification services.
3. No Guarantee of Regulatory Approval
Use of Reginabox templates or services does not guarantee:
- FDA clearance
- CE marking
- Regulatory approval
- Certification
- Audit success
Regulatory outcomes depend on many factors beyond the scope of provided templates, including device design, implementation, testing, and regulatory authority review.
You are solely responsible for the preparation, accuracy, and submission of regulatory documentation.
4. License and Permitted Use
When you receive access to Reginabox templates, you are granted a limited, non-exclusive, non-transferable license to use the materials for your internal business purposes.
You may not:
- Resell, sublicense, distribute, or share templates
- Publish templates publicly
- Provide templates to third parties
- Use templates for commercial resale
- Claim ownership of Reginabox materials
All intellectual property rights remain the property of Reginabox.
5. Intellectual Property
All website content, templates, materials, text, and graphics are the intellectual property of Reginabox, unless otherwise stated.
Unauthorized reproduction, distribution, or modification is prohibited.
6. Consulting Services
If consulting services are provided, they are governed by separate agreements where applicable.
Consulting services do not guarantee regulatory outcomes or approvals.
7. Disclaimer of Warranties
All materials and services are provided “as is” and “as available.”
Reginabox makes no warranties, express or implied, including:
- Fitness for a particular purpose
- Accuracy or completeness
- Regulatory acceptance
- Compliance with any specific regulatory requirement
You use the Services at your own risk.
8. Limitation of Liability
To the maximum extent permitted by law, Reginabox shall not be liable for any:
- Regulatory rejection or delays
- Business losses
- Financial losses
- Indirect or consequential damages
- Loss of data or opportunity
Total liability shall not exceed the amount paid, if any, for access to materials.
9. User Responsibilities
You agree to:
- Use materials responsibly
- Ensure regulatory accuracy of your submissions
- Comply with applicable laws and regulations
- Not misuse or redistribute provided materials
10. Website Availability
We may modify, suspend, or discontinue the website or Services at any time without notice.
We are not responsible for interruptions or technical issues.
11. Refund Policy
Due to the digital nature of Reginabox products, all sales are final once access to templates or materials has been granted.
By requesting access to or purchasing Reginabox templates, you acknowledge that:
- The products consist of digital documentation templates and materials
- Access to these materials provides immediate value
- Once access has been granted, the materials cannot be returned
Accordingly, Reginabox does not offer refunds, exchanges, or cancellations after access has been provided.
If you experience technical issues accessing materials, please contact us and we will make reasonable efforts to resolve the issue.
Nothing in this section limits any rights you may have under applicable consumer protection laws, where such rights cannot be excluded.
12. Privacy
Use of this website is also governed by our Privacy Policy.
13. Modifications to Terms
We may update these Terms at any time.
Updated Terms will be posted on this page with a revised effective date.
Continued use of the website constitutes acceptance of updated Terms.
14. Governing Law
These Terms shall be governed by and interpreted in accordance with applicable laws, without regard to conflict of law principles.
15. Contact
If you have questions about these Terms, please contact:
Email: hello@reginabox.com