Terms of Service

These Terms of Service ("Terms") govern your access to and use of the QB510K platform operated by Q BRIDGE AI ("Q BRIDGE", "we", "us"). By creating a tenant, signing in, or otherwise using the Platform, you agree to these Terms on behalf of yourself and the organisation you represent.

1. What QB510K is — and what it is not

QB510K is a software platform that helps U.S. medical device manufacturers prepare 510(k) submissions. It drafts artifacts using AI agents and records every decision in a 21 CFR Part 11 audit chain.

The Platform is not a substitute for licensed regulatory, legal, or medical counsel. Every artifact the Platform produces is a draft that a named human regulatory lead must review and approve through the Gate workflow before it is acted upon. FDA decisions on clearance, classification, or substantial equivalence remain entirely within the discretion of CDRH and CBER.

2. Eligibility and accounts

• You must be at least 18 years old and authorised to bind your organisation.
• You will provide accurate registration details and keep them up to date.
• You are responsible for safeguarding your password, electronic-signature PIN, and (when enrolled) WebAuthn second factor.
• You will notify us promptly of any suspected unauthorised access.

3. Acceptable use

You agree not to:

• Upload patient identifiers, electronic protected health information (ePHI), or any data you are not authorised to share.
• Use the Platform to attempt to defraud the FDA, falsify records, or evade Part 820 / Part 11 obligations.
• Circumvent the Gate workflow, fabricate signatures, or otherwise tamper with the audit chain.
• Reverse-engineer, decompile, or attempt to extract the underlying source code, prompts, or model weights.
• Resell or sublicense access to the Platform without our prior written consent.
• Use the Platform to violate any applicable law, including U.S. export controls.

4. AI-generated content

The Platform uses third-party large language models to draft regulatory text. Drafts may contain errors, omissions, or hallucinations, particularly for novel device classes, recently issued guidances, or edge cases. You are responsible for reviewing every AI-generated artifact before signing it. The Gate workflow exists precisely to enforce this responsibility.

Predicate citations and FDA product codes are looked up against live FDA databases at draft time and the lookup is logged. You are still responsible for verifying that any cited record applies to your device.

5. Your content and our content

You retain ownership of the device data, submission drafts, and correspondence you upload (your "Content"). You grant Q BRIDGE a worldwide, non-exclusive, royalty-free licence to host, process, and display your Content solely to deliver the Platform to you, maintain the audit chain, and meet our legal obligations.

QB510K, its agents, prompts, code, models, designs, and documentation are owned by Q BRIDGE and protected by intellectual-property law.

6. Fees

Pricing is set by separate written agreement. Pilot tenants on the Platform may be subject to usage limits and feature gates. We will notify you in advance of any material change that would affect your tenant.

7. Service availability

We work to keep the Platform available, but we do not guarantee uninterrupted operation. Scheduled maintenance, third-party outages, and force-majeure events may cause downtime. The Platform is provided "as is" and "as available" without warranties of merchantability, fitness for a particular purpose, or non-infringement, except where such warranties cannot be disclaimed under applicable law.

8. Limitation of liability

To the maximum extent permitted by law, Q BRIDGE will not be liable for any indirect, incidental, special, consequential, or punitive damages, or for any loss of profits or revenue, whether incurred directly or indirectly, arising out of or related to your use of the Platform. Our aggregate liability for any claim arising out of or relating to these Terms is limited to the amounts you have paid us in the twelve months preceding the claim.

9. Indemnification

You agree to defend, indemnify, and hold harmless Q BRIDGE and its officers, employees, and agents from any claims or losses arising from your Content, your use of the Platform in violation of these Terms, or your violation of applicable law.

10. Termination

You may stop using the Platform at any time by closing your tenant. We may suspend or terminate access if you materially breach these Terms or if continued access would create legal or safety risk. The audit chain, signed Gate manifests, and any records required by 21 CFR Part 11 will be retained as described in our Privacy Policy.

11. Governing law

These Terms are governed by the laws of the State of Delaware, without regard to its conflict-of-laws principles. Disputes will be resolved in the state or federal courts located in Delaware, and you and we each consent to that jurisdiction.

12. Changes to these Terms

We may revise these Terms from time to time. Material changes will be announced to account administrators by email at least fourteen days before they take effect. Continued use of the Platform after the effective date constitutes acceptance of the revised Terms.

13. Contact

Questions about these Terms? Write to vamsy@qbridge.ai.