We built this from the inside.

Eight years inside the electronic-IFU industry before we started Idntfy. Long enough to know what a notified body actually asks for, and where the existing tools stop short. This page is who we are, why we started, and how we intend to operate.

Focus

eIFU only

For medical device and IVD manufacturers

Data residency

EU hosted

Platform and database run in AWS EU regions

Headquartered

Belgium

Province of Antwerp

Founded

2026

Platform built from scratch

Where this came from.

Hosting a PDF is the smallest part of electronic instructions for use. We started Idntfy to solve the rest.

We built Idntfy to take on the work around the document. It imports your devices from EUDAMED and shows where your catalogue and your EUDAMED records differ. It warns you when a language or document is missing for a market you sell in. It publishes each version per country on the date you set, and it keeps the record an auditor will ask for.

That work has grown with the rules. EU MDR is in full application, IVDR deadlines are approaching and EUDAMED is maturing. Professional-use manufacturers of every size now have to keep catalogues, languages, markets and versions aligned, and be able to prove it.

The platform is ready to use today and grows with your catalogue. We keep developing it around the problems manufacturers bring to us.

Five commitments, written down.

We publish these so that you can hold us to them. Tell us if we fall short.

Solve the real problem

We build for the work that takes up a regulatory team’s time: checking coverage, controlling versions and preparing evidence. Every feature has to reduce that work.

Regulatory honesty

We state clearly what we are and are not. “Built to ISO 13485” is not the same as “ISO 13485 certified,” and we will not blur that distinction in a sales conversation.

No lock-in

Your data is yours. Export it on demand, in formats your next platform can read. If we stop being the right fit, helping you leave cleanly is part of the job.

The end-user matters

The quality team is our customer; the clinician or technician holding the device is our customer’s customer. Both deserve software built for them.

Built for every size of manufacturer

A company bringing its first device to market and a group with thousands of products face the same obligations. We build the platform to serve both, and we will tell you if it is the wrong fit.

Who is responsible for what.

You will work directly with the people who design and run the platform. When you ask how something works, the person answering is the one responsible for it.

Koen Stynen

Co-founder · Engineering & Regulatory

Koen leads engineering and the regulatory side of Idntfy, including backend services, cloud infrastructure and regulatory data modelling. That experience shaped a platform built for regulated work from the start.

He is the person to ask why anything in the product works the way it does, and the one keeping the compliance assumptions documented and defensible as the rules evolve.

Responsible for

Engineering and hosting
Information security
Regulatory decisions

Thomas Wouters

Co-founder · Commercial Strategy & Business Development

Thomas has more than 15 years of experience in technology and telecommunications, in senior roles across sales, business development and strategic transformation. He knows how to turn technology into tangible business value for customers and partners.

At Idntfy, he leads commercial strategy, business development and strategic partnerships. His focus is on making complex information and documentation processes more accessible, efficient and manageable for organisations.

Responsible for

Commercial strategy and business development
Strategic partnerships
Deputy for regulatory contact

See how Idntfy fits your catalogue.

A short conversation is the quickest way to judge the fit. We will look at your portfolio and tell you plainly whether electronic IFU makes sense for it yet.

Book a demo