Follow your instructions for use
from approval to audit.
You approve the instructions for use in your quality system. Idntfy does everything after: publishes them per market, puts them in front of the right clinician in the right language, and keeps the record.
No consultant. No implementation project. No one hired to run it.
Idntfy starts where your quality system stops.
We don't review or approve your instructions for use. That happens in your quality system, and you're not going to replace it. We take the approved file and handle everything downstream: publication, languages, markets, discovery, paper copies, updates, and the evidence that all of it happened. Built for medical device and IVD manufacturers under MDR and IVDR.
Where your team works.
The catalogue, versions, markets, languages, and the evidence. Only your people see it.
What your customers see.
Your brand, your domain, their language. A clinician never knows we exist.
01Start with everything you already have.
Admin portal
You have the documents. They're approved, and they're on a shared drive.
Get them in whichever way suits the size of the job: one at a time in the portal, two hundred at once from a spreadsheet, or pushed straight from your own systems over the API.
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A product's Details tab: device name, REF code, description, UDI-DI, the family it belongs to, GMDN code, risk class, MRI safety, and the sterile and single-use flags.
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A product's Documents tab: a quick reference guide inherited from its family, with four active versions (French, German, Italian and Spanish), each live in its own country from the same date, with no end date.
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The Idntfy bulk import wizard, part-way through a five-step import, mapping spreadsheet columns onto product fields.
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The import wizard's validation step: all checks passed, with counts of the products, documents and versions the file would update, and nothing committed yet.
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The import history: four runs listed with their date, status, file, a created-and-updated summary, and who ran them.
02Publish per market. On the date you choose.
Admin portal
A version carries three things: the date it takes effect, the countries it's valid in, and the languages it exists in. Set them once.
On that date it goes live. Not before. So you can prepare a label change months ahead and stop thinking about it.
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Countries and languages live on the version: update French without touching German.
MarketDEFRITNLESLocal languagerequireddefritn/aesCurrent versionlive todayv1.4v1.4v1.4—v1.3Status1 JuneLiveLiveLiveNot soldScheduled -
A document's version list: three archived revisions, one scheduled to take effect on a future date, and the current revision live per country and language.
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The market-coverage tab of a product family: six countries, each with the date the family became available there, and a count of products overriding it.
03Then it leaves your hands.
Something has to go on the box. You have two ways to do it.
Put a QR code on the label
It goes straight to that product's page. Nothing to read, nothing to type.
Or print your portal's address
People search when they get there, using the REF code already on the packaging.
Most manufacturers pick one. Both work, and nothing stops you changing your mind later. The product page is at the same address either way.
04Someone goes looking.
Public portal
Either way they arrive at the same place, and they're two taps from the document.
They're in Italy, so they get Italian, valid for Italy. If you don't sell there, they're told so plainly, rather than handed a document that doesn't apply to them.
All 24 official EU languages. And seven more.
Every language you're obliged to publish in, plus Arabic, Hebrew, Japanese, Korean, Russian and both written forms of Chinese. Right-to-left included. That's the portal itself. The documents you publish through it can be in any language your markets require. If a portal language is missing, ask us. We add it free of charge.
And it's your brand.
Your logo, your colours, your domain. The clinician never sees us.
05Some people need it on paper.
Public portal Our desk
The regulation is explicit: a paper copy on request, free of charge, within seven days.
There's a request form on every product page. The request comes to us, not to you. We print it and post it.
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The paper-copy request form on a manufacturer's public portal, offering delivery by email or by post within seven days.
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The paper-copy request queue: four requests with their status, delivery method, requester and a countdown to the service-level deadline.
06Version 1.5 replaces version 1.4.
Both portals
Upload the new version, set when and where it applies, then archive the old one. Three things. Everyone following that product gets an email. You don't send it. They don't have to check.
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A product's Documents tab: a quick reference guide inherited from its family, with four active versions (French, German, Italian and Spanish), each live in its own country from the same date, with no end date.
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The market-coverage tab of a product family: six countries, each with the date the family became available there, and a count of products overriding it.
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Version 1.4 doesn't disappear. It stays reachable for as long as you need it to be.
07Then someone asks you to prove it.
Admin portal
A Notified Body wants to know what was published, where, in which language, and when it changed.
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The download analytics dashboard: total downloads, unique documents and products, top country, and downloads per day over the past month.
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The audit log filtered to document changes: each row names the person, what they did, which document, and when, with filters for change type, user and date range, and a CSV export.
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An entity's activity trail: who changed what and when, with the previous value struck through beside the new one.
For the people who ask the harder questions.
Your IT and security colleagues will have a list. Here's what we can answer without a meeting.
Single sign-on
OpenID Connect. Microsoft Entra, Okta and Google. Users are routed to the right identity provider by their email domain.
Roles
A set of standard roles covering the people who actually touch the catalogue. Underneath them sits a permission model of 30 distinct rights, so when custom roles arrive you won't be migrating anything.
Tenant isolation
A separate database schema per customer. Separate, not filtered.
Audit
Every change to every record: who, when, and the previous value.
Custom domains
Your domain, your DNS. Certificates issued and renewed for you.
Hosting
AWS in Ireland. Your data stays in the EU.
Quality system
Built under a quality system aligned to ISO 13485 and IEC 62304, with an ISMS run to ISO 27001. We operate as if certified; certification is planned.
What's next.
Quarters, not dates. In development means we're building it now. Planned means we know the shape and haven't started.
Coverage gap detection
You sell in twelve countries. Your documents cover nine. Idntfy tells you which three, before someone else finds them.
Custom roles
Build the roles your team actually has, instead of fitting into ours.
Publication review
A second pair of eyes on the markets, languages and effective date before a version goes live.
Thirty minutes, your catalogue, honest answers.
We'll walk through the product against your actual situation: what's there, what isn't, and whether we're the right fit. If we're not, we'll say so.