About us

Compliance shouldn't require an enterprise budget.

We started YDNTFY because the tools that meet the regulation are priced for the largest manufacturers, and everyone else is left to improvise. This page is who we are, why we started, and how we intend to operate.

Founded
2026
Platform ready, pre-revenue
Operating entity
Ydntfy BV
Belgian BV, in formation (in oprichting)
Headquartered
Belgium
Province of Antwerp
Team
Two founders
Engineering and commercial
01 · Origin

Where this came from.

Not a pivot or a side project, but a response to a gap we watched go unaddressed for years inside the electronic-IFU industry.

We spent years inside the electronic-IFU industry, at the same employer, on different sides of the business. Long enough to see the same pattern repeat: a smaller device manufacturer would ask whether there was a version of the platform that fit their budget, and the answer was almost always no. Not for a technical reason, but because that manufacturer was never who the platform had been built for.

The regulatory environment kept tightening in parallel. EU MDR in full application, IVDR timelines approaching, EUDAMED maturing, and the electronic-IFU provisions drawing every professional-use manufacturer into the same question of what compliance now requires. Smaller manufacturers, which make up most of the market, were left with three options: pay enterprise prices for capabilities they did not need, host PDFs on a marketing site and hope the approach held up under audit, or stay on paper.

We founded Ydntfy BV to build a fourth option: the same audit-ready capability, priced and scoped for the companies the incumbents overlook. The founding team is two people, an engineering lead who has built this category of software before, and a commercial lead with a long background across medical device and life sciences.

The platform is built and ready to use. This site is our first commercial step, and we're ready to onboard the smaller manufacturers it was made for.

02 · What we believe

Five commitments, written down.

Publishing these is a commitment, not a slogan. If we ever fall short of one, our contact address is at the bottom of the page.

01
Transparent pricing

Our pricing is published. Where a situation genuinely needs a custom quote, we put it in writing with line items, rather than turning price into a negotiation.

02
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.

03
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.

04
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, not a regulatory checkbox.

05
Built for SMEs, deliberately

We will not retrofit enterprise pricing once we have momentum. The cost structure is meant to stay where it started.

03 · Founders

A small, focused team.

Small enough that you will meet a founder on a demo call. Each of us owns a side of the business the other is glad not to.

KS
Koen Stynen
Co-founder · Engineering & Regulatory

Koen leads engineering and, for now, the regulatory side of YDNTFY: backend services, cloud infrastructure, regulatory data modelling, and the multi-tenant foundations most teams would rather not build. It is the kind of background that lets a small team ship a product able to stand next to a much larger one.

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.

Based Belgium · near Geel
LV
Luc Van Steyvoort
Co-founder · Commercial

Luc leads the commercial side of YDNTFY, after a long career across medical device and life-sciences sales. His approach is straightforward: explain what the platform costs, explain what it does, and let the customer decide.

He is usually the first person a prospect meets. He will walk you through the product, ask direct questions about your situation, and give an honest view of whether YDNTFY is the right fit, including when it is not.

Based Belgium
04 · Where we are

Belgium, by design.

A small Belgian team in a region with a dense medical-device and life-sciences base. EU data residency, and EU suppliers wherever the choice exists.

Operating entity
Ydntfy BV Belgian besloten vennootschap (private limited company)
Headquartered
Belgium Province of Antwerp
Data residency
EU only AWS EU regions, with no transatlantic transfers by default
How we work
Remote-friendly Demos are usually remote; in person when it helps.

Want to meet the team?

The best way to judge whether YDNTFY fits is a short conversation. No slides and no pressure, just an honest read on whether electronic IFU is your move yet.

Book a demo