The right instructions, in the right language, for every market, without turning your IFUs into a compliance liability.
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.
Relabel, rework, field action, on stock already shipped.
Box size, insertion step, reprint per change, a tax on every unit.
Aggregators republish unasked. Customers find their version, not yours.
Gone or unreadable exactly when someone needs the instructions.
Every one of these has the same fix: electronic IFU, done properly.
Same typo. Two completely different days.
The field sees what you approved, not an old print.
Proof of availability, plus a live post-market signal.
New market = a file upload, not a print run.
Smaller boxes, no insertion step, no reprints.
Searchable, zoomable, accessible: the right instruction in seconds.
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.
Hosting a PDF is the easy 10%. The 90% a regulator cares about sits below the surface.
Genuinely easy. Also the only part most plans ever budget for.
A tampered IFU isn't just a breach, it's a labelling failure.
Every change reopens it. Indefinitely, on your time.
Change records, versions, access logs, as a package, not a panic.
Uptime, backup and disaster recovery have to be engineered.
Patches, upgrades, renewals, pen-tests. Nobody budgets those.
“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.
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.”
Built to 13485 & 27001 from day one. Certification in progress, by design beats bolted on under deadline.
Going electronic is a real project. We've run it many times, never a checklist and good luck.
The same audit-ready platform, from €350/mo. No minimums, no enterprise tax.
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.
Three layers. Customers live in the first, your team in the second, the third runs itself.
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.
Configure, bulk-upload your catalogue, and operate. SSO, bulk tools and an API make going live a task, not a project.
The entire iceberg from two sections ago, built, maintained and kept compliant, so it never becomes your weekend.
The number, on the page, where it belongs. No surprises, no hidden tiers, no quote to chase.
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.
Book 30 minutes. We'll show you the platform, map your portfolio honestly, and tell you straight whether eIFU is your move yet.