Enterprise-grade eIFU. Without the enterprise tax.
Electronic instructions for use for medical device and IVD manufacturers — the right document, in the right language, for every market you sell in.
Paper feels safe. That's exactly the problem.
Every printed copy in the field is a quiet bet that nothing important has changed.
Somewhere right now, a clinician is following instructions you would recall if you could.
With paper, you can't. Not without a field action.
A typo becomes a recall
Relabel, rework, field action, on stock already shipped.
Packaging sized by a booklet
Box size, insertion step, reprint per change, a tax on every unit.
Out of your control
Aggregators republish unasked. Customers find their version, not yours.
Paper fails at the worst time
Gone or unreadable exactly when someone needs the instructions.
Every one of these has the same fix: electronic IFU, done properly.
The recall becomes a five-minute fix.
Same typo. Two completely different days.
And six more reasons to go electronic.
Always current in the field
The field sees what you approved, not an old print.
Per-country usage data
Proof of availability, plus a live post-market signal.
Languages at scale
New market = a file upload, not a print run.
Lighter packaging & logistics
Smaller boxes, no insertion step, no reprints.
Built for the clinical moment
Searchable, zoomable, accessible: the right instruction in seconds.
Subscribe to updates
Users notified the moment a version changes.
Paper doesn't vanish entirely. A free paper copy on request, within 7 days, stays, built into the workflow, so it's handled, not forgotten.
Does my device qualify?
Six questions decide it, and the answer changed in July 2025. If you checked before then and the answer was no, that answer may be out of date.
- Does the device need instructions for use at all?
- Is it a device under the MDR?
- Is it intended for use by professional users?
- Is use by lay persons reasonably foreseeable?
- Does your risk assessment show safety is maintained or improved?
- Can you hold the conditions for the full 10 or 15 years?
“It's just a website.” Except… it never is.
Hosting a PDF is the easy 10%. The 90% a regulator cares about sits below the surface.
“Just put the PDFs on a page.”
Genuinely easy. Also the only part most plans ever budget for.
Security is a job, not a setup
A tampered IFU isn't just a breach, it's a labelling failure.
Validation never ends
Every change reopens it. Indefinitely, on your time.
Audit evidence you can't fake at 11pm
Change records, versions, access logs, as a package, not a panic.
Down during an audit is a non-conformity
Uptime, backup and disaster recovery have to be engineered.
Year two is what sinks DIY
Patches, upgrades, renewals, pen-tests. Nobody budgets those.
So do the real maths.
“Just a website” quietly bundles development, validation, security, availability and audit. Add every line and the platform isn't the expensive choice, it's the cheap one. And when the rules shift again, our problem, not yours.
We made compliance accessible.
Built by the team behind a leading eIFU platform, years of onboarding manufacturers big and small.
“Compliance shouldn't be a privilege of the largest manufacturers. Every company deserves documentation that is controlled, current and trustworthy, at a price that fits its size.”
ISO by design, not bolt-on
Built to 13485 & 27001 from day one. Certification in progress, by design beats bolted on under deadline.
We walk the journey with you
Going electronic is a real project. We've run it many times, never a checklist and good luck.
Priced for every company
The same audit-ready platform, from €350/mo. No minimums, no enterprise tax.
It's when, not if, and you know it.
Since 2025, eIFU is open to every professional-use device. Regulators and the industry keep moving this way, so the shift to electronic is only becoming more expected.
Simple where it shows. Serious where it counts.
Three layers. Customers live in the first, your team in the second, the third runs itself.
Scan. Find. Confirm. Done.
A QR code or a search box, the right document in the right language, a confirm step so nobody walks off with the wrong version.
Set it up once. Run it in your sleep.
Configure, bulk-upload your catalogue, and operate. SSO, bulk tools and an API make going live a task, not a project.
The whole DIY list. Already handled.
The entire iceberg from two sections ago, built, maintained and kept compliant, so it never becomes your weekend.
That's the shape of it. Walk through the product itself — every stage, on real screens.
Enterprise-grade. Not enterprise-priced.
The number, on the page, where it belongs. No surprises, no hidden tiers, no quote to chase.
- Priced by product lines, never documents or headcount
- Every feature from day one, nothing paywalled
- The same platform at 1 product line or 1,000
- Up to 5 product lines
- Unlimited documents & languages
- White-label public portal
- Full audit package
- SSO, bulk import & API
The things people ask us first.
Not entirely. A free paper IFU on request, within 7 days, stays, and some devices keep paper where lay-person use is reasonably foreseeable. What changes: the authoritative version lives in one controlled place, and the paper-request workflow runs itself.
Everything a Notified Body looks for, from security and availability to version control and the website requirements, is what the platform is built to satisfy. We enable compliance; the conformity assessment is still yours to sign.
The platform is the easy part; the regulatory change is the real work: risk assessment, supplier qualification, labelling SOPs, training, and a packaging and logistics review wherever paper comes out. We have walked this road many times and walk it with you.
In the EU, full stop. Encrypted in transit and at rest, GDPR-aligned, built to tick the EU-data-residency procurement checkbox without an asterisk. Need another region? Let's talk.
You do, always. We act purely as a processor: never selling, sharing or repurposing your data. Export everything through the API at any time; if you leave, we return your data and delete it on request. No lock-in.
Availability is the whole point of an eIFU. The platform runs on AWS with a high-availability, multi-zone architecture and continuous monitoring. Need a formal SLA? Happy to agree the right terms for your contract.
Today: bulk upload and a well-documented REST API to move data in and out. Specific QMS or PIMS connections get built when customers ask for them, tell us what you run.
Yes, OIDC, so virtually any identity provider works: Microsoft Entra, Okta, Google Workspace and the rest. Your team signs in with the credentials they already use.
Completely. Point your own domain at the public portal and shape the look with built-in styling tools for colours, logo, typography and layout, no developer needed. The result reads as your website; YDNTFY runs quietly behind the scenes.
Not yet, and here is the honest reason: certification requires documented operating evidence, a functioning QMS and ISMS with real records, which a company our age cannot have yet. We build to both standards from day one, certification in progress, and we are happy to show the records behind that claim. Built in by design beats bolted on under deadline.
EUDAMED XML export is on our roadmap for Q4 2026. Further registry integrations like GUDID, Swissmedic and others follow as customers need them; tell us which registries you file with.
Still have a question we didn't cover? Get in touch and we'll talk it through.
Compliance shouldn't be a luxury.
Book 30 minutes. We'll show you the platform, map your portfolio honestly, and tell you straight whether eIFU is your move yet.