"Regulatory compliance isn’t a cost centre. It’s a capability that can be built up."

Nakamo is a Swiss technology company founded in 2025 in Baden, Switzerland. With Flurina, the latest regulatory AI companion for medical device manufacturers, the seven-person team has developed a solution that supports regulatory teams throughout the entire product lifecycle.

Thierry, what inspired you to found Nakamo? What did you see in the industry that others hadn’t yet addressed?

I worked closely with a medtech company for several years. During that time, I saw just how much expertise there is within regulatory teams, and yet how much energy is still spent on repetitive tasks.

At the same time, I am currently witnessing a fundamental shift in my own industry, software development. AI hasn’t simply sped up processes there. It has changed roles. Today, a designer develops user interfaces independently. A developer takes on tasks that previously required a separate team. People are working outside their traditional areas of expertise because AI enables them to familiarise themselves with new domains more quickly and operate at a higher level within them.

And I see exactly the same potential in regulatory work. Engineers who scrutinise regulatory aspects right from the development stage. Regulatory experts who actively help shape product decisions. What are still separate worlds today are converging.

The tools for this already exist. Someone needs to build them for MedTech. That’s what we’re doing with Nakamo.

For many people, AI in medical technology still sounds like something from the future. What would you say to a managing director who says, "That’s interesting, but it’s not for us yet"?

I hear that a lot. And I understand the caution. But that’s exactly why we built Nakamo. Nakamo integrates with your existing SharePoint; your team simply opens the interface and can get started straight away. No migration, no change of platform. Nakamo analyses your existing documentation, checks for consistency and completeness against regulatory requirements, and gives your team a capability from day one that no human could achieve on this scale.

But Nakamo does even more. Teams working with Nakamo begin to change. Engineers start to question regulatory content themselves, because Nakamo enables them to do so. Regulatory specialists spend less time on systematisation and more on interpretation and strategy, because Nakamo takes care of the systematic work. Regulatory work transforms from a burden into a capability that the company actively builds up.

This change takes time. It grows with every week a team works with Nakamo. A company that starts with Nakamo today will have twelve months of this experience in a year’s time. A company that waits has none. And those twelve months cannot be made up for. That is why, in my view, there is no such thing as ‘too early’. Only ‘too late’.

Flurina works with existing documentation. What happens if a manufacturer realises that their documents aren’t perfectly structured?

Then that’s exactly the right time. Flurina works with what’s already there: Word files, Excel spreadsheets – the tools that teams use and are already familiar with. There’s no need to switch platforms or migrate data. Nobody has to change the way they work.

What Flurina does: it reads the existing documentation, checks consistency, traceability and completeness against regulatory requirements, and highlights where action is needed. When several people work on the same documents over a period of months, contradictions inevitably arise. These are usually only noticed during gate reviews, when hundreds of pages are checked all at once. Flurina brings this moment forward. Problems become visible when action can still be taken, not when a milestone is at stake.

And where this leads: an AI that not only checks written content but actively questions it. Is more being done here than required? Or too little? Is the effort proportionate to the requirement? Not as a check, but as a sparring partner — so that teams do exactly what is necessary. No more and no less.

What should manufacturers visiting MedtecLIVE be sure to ask or bring with them to make their visit to the stand worthwhile?

Come along with an open mind and a sense of curiosity. Whether you have a specific regulatory question or simply want to know where AI stands in regulatory work today — both are perfectly fine. Where does regulatory work currently take up the most of your company’s resources? Where would you like your team to be able to focus on the work that really matters? We’d be happy to show you live how Flurina works. And we’ll talk openly about where AI is making a concrete difference today and where it isn’t yet. We look forward to the discussion.

Nakamo AG will be exhibiting at MedtecLIVE 2026. Come and visit us to see Flurina in action in Hall 3 / 3-406.

You can find further information on our website or our LinkedIn page.