Terms of Service

These Terms of Service ("Terms") are an agreement between you and [Legal entity name, registered address] ("Regway", "we", "us"). They cover the Regway website, web application, client review links and API (together, the "Service").

By creating an account or using the Service, you accept these Terms. If you use Regway for a company or firm, you accept them on its behalf and confirm you have authority to do so. In that case "you" means that organization.

If you have signed a separate written agreement with us, that agreement takes precedence where it conflicts with these Terms. Our Privacy Policy explains how we handle personal data.

• You must be at least 18 and give accurate account information.
• Each account belongs to an organization. Organization owners and admins manage members, clients, branding and API keys, and are responsible for who they invite.
• Keep your password and API keys secret. You are responsible for activity under your account and your organization's keys. Tell us right away at hello@regway.ai if you suspect unauthorized access.
• One person per user account. Don't share logins.

You agree not to:

• Upload protected health information (PHI) as defined by HIPAA, or other patient-identifiable health data, unless we have agreed to it in writing first. Regway is built for device and regulatory documents, not patient records. De-identify clinical data before you upload it.
• Upload content you don't have the right to use, or that breaks the law or someone else's rights.
• Try to access another organization's data, or probe, scan or test the Service's security without our written permission.
• Get around rate limits, usage quotas or access controls, or overload the Service.
• Scrape the Service, or use it or its output to build a competing product or train AI models.
• Reverse engineer the Service, except where the law allows it.
• Resell or sublicense access to the Service without our agreement.
• Use the Service to mislead FDA or any regulator, for example by submitting content you know is false.

Customer Content means everything you or your users put into the Service, such as device descriptions, documents, test reports and client information, and everything the Service generates for you from it, such as drafts, tables, analyses and exports.

• You own your Customer Content, both your inputs and the outputs generated for you. As between you and us, we claim no ownership of it.
• You confirm you have the rights and permissions needed to upload it, including your clients' permission where you act for them.
• You can export your submission documents at any time (PDF, Word or Markdown).

Regway owns the Service itself: the software, templates, design, and our compiled and indexed versions of FDA data. These Terms don't transfer any of that to you.

You give us a limited licence to host, copy, process, transmit and display Customer Content only as needed to provide, secure and support the Service for you, including sending it to the AI providers listed in our Privacy Policy.

We don't use Customer Content to train AI models, and we don't sell it or use it for marketing. The licence ends when your content is deleted from the Service, apart from backup copies that expire on their normal schedule.

If you send us feedback or suggestions, we may use them freely without any obligation to you.

• Output can be wrong. AI-generated content, including predicate suggestions, classifications, pathway recommendations, readiness scores and drafted sections, can be inaccurate, incomplete or out of date, even when it cites a source.
• A qualified person must review it. You are responsible for checking every output against the source records and current FDA requirements before you rely on it or include it in a submission.
• You own the submission. You decide what to submit to FDA or any other regulator, and you are solely responsible for its content, accuracy and outcome. Regway does not submit on your behalf and does not guarantee clearance, approval or any review outcome.
• Not affiliated with FDA. Regway is independent. It is not affiliated with, endorsed by or acting for the U.S. Food and Drug Administration or any government agency.

Regway uses public FDA information, such as 510(k), De Novo and PMA records, classifications, recalls, adverse-event reports and guidance documents. We copy and index it so it's searchable, and link back to sources where we can.

This data is provided as is. FDA records can contain errors, our copy may lag behind FDA's latest updates, and processing can introduce mistakes. Always confirm important facts on FDA's own website.

Organization owners and admins can create API keys to read project data from the Regway API, for example to pull traceability into a quality system.

• The API is read-only. Keys belong to your organization and can see its projects.
• Treat keys like passwords. Each key is shown once; revoke any key that may be exposed. You are responsible for every request made with your keys and for protecting data once your systems receive it.
• Stay within the rate limits and usage limits we publish or set. We may throttle or suspend a key that harms the Service or other customers.
• We may change or version the API. We'll give reasonable notice before removing anything you rely on, unless a change is needed for security or legal reasons.

You can share selected draft sections with a client through a review link, or share a compiled document through a shared link. Anyone with the link can open it without a Regway account, and review links let them comment on or approve sections.

• You choose what to share and who receives the link. Only send it to people allowed to see the content.
• Review links expire after 30 days by default (90 days at most). You can revoke any link at any time.
• A link shows a frozen copy of the content at the time you shared it, with your organization's branding if you set it.
• People who use a review link must follow the acceptable use rules in section 3.

Regway is currently available on a free trial. The trial includes a monthly limit on AI runs (actions that use our AI models), shown in the app. When you reach it, AI features pause until the next month (or until you move to a paid plan, once they are available).

We plan to offer paid plans later. We'll publish their prices and terms before charging anything, and you'll only be charged if you choose a paid plan. We may change trial limits with reasonable notice.

We treat your Customer Content as confidential. We only use it to provide the Service, and only share it with our staff and subprocessors who need it for that purpose and are bound by confidentiality obligations.

You agree to keep confidential any non-public information about the Service we share with you, such as pricing proposals, roadmaps or security documentation.

These duties don't cover information that is public through no fault of the receiving party, was already known to it, or is independently developed. Either party may disclose information when the law requires it, giving notice first where allowed.

• You can stop at any time. To close your organization and delete its data, email hello@regway.ai from an owner's address.
• We may suspend access if you breach these Terms, if your use puts the Service or other customers at risk, or if the law requires it. Where practical, we'll tell you first and give you a chance to fix the problem.
• We may end the Service or a free plan with at least 30 days' notice.
• Exporting your data. Unless we suspend you for a serious breach or a legal reason, you'll have at least 30 days after termination to export your documents. On request, we'll provide your Customer Content in a portable format. After that we delete it as described in our Privacy Policy.

Sections that by their nature should survive (ownership, disclaimers, liability, indemnity and governing law) continue after termination.

To the fullest extent the law allows, the Service, including AI output and FDA data, is provided "as is" and "as available", without warranties of any kind, express or implied, including merchantability, fitness for a particular purpose, accuracy and non-infringement. We don't warrant that the Service will be uninterrupted or error-free, or that any output will be accepted by FDA.

To the fullest extent the law allows:

• Neither party is liable for indirect, incidental, special, consequential or punitive damages, or for lost profits, revenue, data or business opportunity, including delays or refusals of a regulatory submission.
• Each party's total liability arising from these Terms or the Service is limited to the greater of the fees you paid us in the 12 months before the claim, or US$100.
• These limits don't apply to your payment obligations, your breach of acceptable use, either party's indemnity obligations, or liability that can't be limited by law.

You will defend and indemnify Regway against third-party claims arising from your Customer Content, your submissions to regulators, or your breach of these Terms or the law, including claims from your clients about data you uploaded or shared. We will tell you promptly about any such claim and let you control its defense, and you won't settle it in a way that admits fault for us without our consent.

These Terms are governed by the laws of [Governing law: to be confirmed], and disputes will be heard in the courts of [Venue: to be confirmed], except where the law of your country gives you rights that can't be waived.

We may update these Terms as the Service changes. We'll change the date at the top, and for significant changes we'll notify account owners by email or in the app before they take effect.

If you keep using the Service after a change takes effect, you accept the updated Terms.

General

These Terms are the whole agreement between us about the Service, unless a separate written agreement says otherwise. If part of them is unenforceable, the rest still applies. Not enforcing a right isn't a waiver of it. You can't transfer these Terms without our consent; we may transfer them in a merger, acquisition or sale of assets. Neither party is liable for delays caused by events beyond its reasonable control.

Contact

Email hello@regway.ai.
Postal address: [Legal entity name and registered address]