Your field rep can't be everywhere. Your product guide can.

SIMPI turns your existing IFU and training materials into a branded, step-by-step guide that lives on your device, in any language your professional users need, on any phone, without an app.

Simpi Guide
Professional-use device
STEP 04 Confirm the connection.

Check the indicator before the next function.

Three problems every medtech company knows

Underutilized equipment

A customer bought the premium device and is using 40% of its features, because the advanced functions were covered on slide 47 of a training deck someone half-remembers. SIMPI puts that guidance at the point of use, a clinician scans the QR code on the device, finds the specific function, and follows the steps. No manual, no call to the field rep, no quietly switching to a simpler competitor device.

Staff turnover erasing your training investment

You trained 8 nurses in March. 3 are gone by June. The 4 who replaced them never got the training, the device is still in use, the guidance isn't. SIMPI is always there. Every new staff member gets the same guided experience on demand, without anyone being called. The training investment doesn't leave when the trained nurse does.

Markets you can't afford to support directly

Your device is in 14 countries. Your field team properly covers 6 of them. The other 8 run on a printed manual, a single onboarding session, and good intentions. One guide, translated once, published everywhere, closes that gap without new field headcount.

What this looks like in practice: a nurse in Lisbon who joined last month scans the QR code on the device. She gets a branded, step-by-step guide in Portuguese, the same guidance your best field rep would give her, at 2am, without anyone being called. Short steps, voice guidance, visuals, a link to support if she needs it. No app, no account, no training session required.

EU rules now favor exactly this

Electronic instructions for professional-use medical devices aren't a workaround. They're explicitly provided for, and recently expanded.

Implementing Regulation (EU) 2021/2226 sets the rules for electronic instructions for use (eIFU) under the EU Medical Devices Regulation. In 2025, it was expanded by Implementing Regulation (EU) 2025/1234, widening eIFU to cover all MDR devices and accessories intended for professional use, specifically because regulators found healthcare professionals prefer electronic instructions and need faster, more reliable access to device information.

The scope that matters for you

This applies to professional users, clinicians and technicians using the device in the course of their work, not general consumers. A device used by both professionals and lay users still needs a paper IFU option. Standalone software devices are the exception, those can extend eIFU to lay users directly.

In practice

If your device is professional-use, or has a professional-use pathway, the regulatory door for exactly what SIMPI does is already open. Most manufacturers haven't walked through it yet, they're still shipping a PDF or a printed manual because that's what's always been done, not because it's what's required.

Built for regulated environments

  • All AI-generated content is reviewed and approved by your team before publishing.
  • You control every word, every step, every link.
  • Audit trail available on Enterprise plans.
  • SIMPI does not replace your IFU, it makes it accessible. Paper IFU remains available on request, as the regulation requires, SIMPI doesn't change that obligation, it sits alongside it.

We start with what you already have

No new content to create. No translation agency. No reprint.

01

Send what you already have

Send us your IFU, training materials, or product photos.

02

SIMPI structures the guide

SIMPI extracts the steps, structures the guide, and generates translations.

03

You review and approve

Nothing goes live without your sign-off. Your guide is live before your next field visit.

See what a clinician sees

A branded, step-by-step guide on any phone, in the language they need, without an app.

Simpi Guide
Point of use
PASSO 03 Ligue o sensor.

Siga as etapas no dispositivo.

Questions medtech manufacturers ask

Does this replace our IFU?

No. Your IFU stays as it is, in whatever form your regulatory strategy requires, including paper where that's still needed. SIMPI makes the guidance in it accessible to the people who need it, at the moment they need it, in their language.

How do we handle regulatory review of the content?

You approve every step before it goes live. Nothing publishes without your sign-off. The content is yours, SIMPI is the delivery mechanism.

Does electronic delivery actually satisfy EU requirements, or is this a workaround?

It's provided for directly. Implementing Regulation (EU) 2021/2226, as expanded by (EU) 2025/1234, sets out the conditions for electronic IFU for professional-use medical devices under MDR. It applies to professional users specifically, check your device's use pathway against that scope, and paper IFU must remain available on request regardless.

What happens when our device gets an update or a recall notice?

Update the guide in minutes. The QR code on the device stays the same, no reprint, no field visit required to distribute the update.

Can we see who is accessing the guide and where?

Yes. Analytics show scan volume by geography, drop-off points by step, and which markets are engaging most. Enterprise plans include full data export.

We operate in 14 countries. Can SIMPI handle that?

Yes. One guide, 24+ languages, global delivery. Your QR code works in every market without additional infrastructure.

What about spare parts availability?

SIMPI lets you embed links to the correct, genuine spare part at the relevant step, so your customer's team orders the right part quickly. Independent service providers and in-house biomedical engineering teams retain their own paths to parts and service, SIMPI doesn't block that, and shouldn't claim to.

Start with one product in one market

Send us your existing documentation. We'll build a demo on one of your products so you can see exactly what it looks like before committing to anything.