Niavicta builds nianav OS in the open, with the people who use it.Talk to us ›
Niavicta nianav OS
Talk to us
Build with us

We are building nianav OS now.

We are at the very beginning. The engine that runs regulated work is built and proven. The first version you can log into and use is being built now. Work with Niavicta on nianav OS if you are a medical device company ready to shape it with us before it is finished.

The engine that runs regulated workBuilt & proven
The first version you can log intoIn build now
Design partner placesOpen
Where we are The honest version.

The engine works. The product is being built now.

nianav OS is built engine first. The part that runs regulated work, the procedures, records, corrective actions, and the evidence they produce, already runs from end to end. It is held up by a large suite of tests.

The first version a person can log into and use is being built now. That is where our focus sits today.

We build in the open. You can follow the thinking as it happens, here and on LinkedIn, and you can help decide what gets built next.

We would rather show you the real thing, early, than sell you a finished story.

Who we are looking for A small number of companies, chosen with care.

Medical device companies, in the window before scale.

The best time to put this in place is after the product works and before serious scale. Most companies miss that window. Once it closes, it stays closed. If the four below sound like you, we should talk.

You make a medical device.Hardware, software, or both. MDR or IVDR is already your world, or about to be.
You are past the first proof.The product works. You are heading into your first serious scale-up, the moment everything starts to get heavier at once.
You can feel the foundation is not right yet.You have some compliance structure, and you know it will not hold. You would rather build it right now than rebuild it later.
You want to shape the tool.You would rather influence what gets built than wait for a finished product that was designed around someone else.
If that is your company, this was built for you. We are working with founders and operations leads who know the foundation matters, and want to build it right, with us, now.
What a design partner gets Co-development, with the people who will use it.

We build it with you.

We are building this with a small group of companies because we want to understand your world in real detail, and make it genuinely better. The best version of this is shaped by the people who will use it.

Between the two of us, we hold twenty five years inside regulated medtech. As a design partner, that experience is in the room with you: the kind of quality and compliance guidance companies usually pay consultants a great deal for, built straight into how your company runs.

You help set the direction early, while it is still being shaped, and you help decide what gets built next.

If that sounds like something you want to be part of, shaping the right trajectory while contributing to something bigger, get in touch and we will share the details.

How it starts Plain English. No proposal before we understand the situation.

Tell us where you are and what is breaking.

It starts with a conversation. You tell us how your company runs today, which tools hold which pieces, and where the cracks are. We listen for the real pain, not the tidy version.

If it is a fit on both sides, we show you what we are building and agree how you will shape it. The whole point is that you see the real thing early and help decide where it goes.

The best time is before you need it. That window is shorter than most founders expect.

Build it with us.

Tell us where you are and what is breaking. If it is a fit, we will show you what we are building and how you can shape it.