Terms of Service

510sec · Last updated 2026-09-22

1. What this service is

510sec generates draft cybersecurity documentation for medical-device regulatory submissions from a description of your device. It is compliance tooling. It is not a medical device, it is not a regulatory consultancy, and nothing it produces is legal, regulatory, or medical advice.

2. Drafts require qualified human review

Every document the service produces is a draft and is labeled as such. You are responsible for having each pack reviewed by qualified regulatory and security professionals before it is submitted to FDA or any other regulator, and for the accuracy of everything you file. We do not review, approve, or file submissions on your behalf.

The service does not perform penetration testing, generate testing evidence, produce labeling, or supply security metrics. Those gaps are declared inside every generated pack.

3. Your inputs, your outputs

You retain all rights in the device information you provide and in the documents generated from it. You grant us only the limited licence needed to operate the service for you (storing your specification, generating packs, and providing support you request). We do not use your device data to train models. See the Privacy Policy.

4. Accounts and acceptable use

Keep your credentials confidential; you are responsible for activity under your account. Do not attempt to breach or probe the service without written authorisation (see Security for how to report a vulnerability responsibly), resell access without agreement, or submit unlawful content.

5. Purchases

Packs are sold per device (per submission), in advance. A purchase entitles you to generate and re-generate that device's pack for as long as the service is available to you. Prices are shown before payment. Payments are processed by Square; we never receive your full card details. Refunds: see the Refund Policy.

6. Availability

The service is provided on an "as available" basis. We do not currently offer a contractual uptime commitment; if you need one, contact us before purchasing.

7. Disclaimer of warranties

To the maximum extent permitted by law, the service is provided "as is" without warranties of any kind, express or implied, including fitness for a particular purpose. We do not warrant that a submission prepared using the service will be accepted, cleared, or approved by any regulator, or that generated content is complete or error-free for your specific device.

8. Limitation of liability

To the maximum extent permitted by law, our aggregate liability arising out of or relating to the service is limited to the amount you paid us in the twelve months preceding the claim. We are not liable for indirect, incidental, special, consequential, or punitive damages, or for lost profits, lost data, regulatory delay, or submission outcomes.

9. Term and termination

You may stop using the service at any time and request deletion of your data. We may suspend or terminate access for breach of these terms, or where required by law. Sections 2, 3, 7, 8 and 10 survive termination.

10. Governing law

These terms are governed by the laws of the State of Ohio, USA, without regard to conflict of laws rules. Venue lies in the state and federal courts located in Cuyahoga County, Ohio.

11. Changes

We may update these terms; material changes will be announced in the application and the "last updated" date above will change. Continued use after a change constitutes acceptance.

Questions: support@510sec.com