AI support assistant for medical device companieswithout AI generated answers

Steago puts an assistant on your support page that answers customer and clinician questions with verbatim passages from your approved instructions for use, cited to the exact section.

See it running on your own IFU How it works

No login, no accounts
No personal data by default
Live in under a week

Support page assistant

How should the device be stored between uses?

Verbatim from your IFU

Document: IFU
Version: Rev
Language: EN
Section: §

Opens the document at this heading

Passage text is shown as placeholder here. In a live widget it is your own published wording, unchanged.

The problem

Your support team answers the same 40 questions every week even though your IFU has the answers

Setup. Cleaning and reprocessing. Storage conditions. Error codes. Accessory compatibility. Disposal. What to do when the alarm won’t clear.

All of it is in the IFU. But the IFU is a 180-page PDF that nobody scrolls. So the question becomes a ticket, or an email to a clinical specialist, or a call at 2am – and your team types out an answer that already exists, again.

Why it matters

Using an AI chatbot on your website is labelling. That’s the problem.

Under 21 CFR Part 801, material that accompanies or supplements a device — including your website — is labelling. What it says has to be truthful, not misleading, and consistent with your cleared intended use. That holds whether a person wrote the sentence or a model generated it.

A generative assistant produces a new sentence for every question. Every new sentence is a new claim, and every new claim is yours.

Steago doesn’t write answers. It finds them. The output is text your regulatory team already approved, reproduced exactly, with the document and section it came from. There is nothing new to review.

What you get

Verbatim, or nothing

Every answer is a passage lifted unchanged from your IFU. No rewriting, no blending across documents, no “helpful summary.”

Cited to the section

Users see the document, the version, and a link that opens at the right heading. So does your audit trail.

Silence when it doesn't know

If the IFU doesn't cover it, Steago says so and hands off to your team. It never fills the gap.

Fits your stack

Keep your eIFU portal. Steago sits on top of it.

If you already publish through an eIFU platform, nothing changes: your documents stay where they are, at the URL you registered. Steago indexes what you’ve published and answers from it.

If you publish IFUs as PDFs on your own site, that works too.

See it on your own document

See it answer questions about your device, using your IFU, before you talk to anyone.

Tell us your company name. We’ll build a working demo on your published IFU and send you the link.