The operating system for regulated industries
Your processes run on a dozen tools. Run them on one.
When a tool just moves work between people, it's process-based, so nianav OS replaces it. Your teams, your records, and your work connect in one system, where operations talk to each other and work keeps moving. Audit-readiness is the byproduct, not the pitch.
The whole picture
Everything your operation does, in one place you can click into.
Start anywhere. Each piece below opens the full story.
If it's process-based, it gets replaced.
Sixteen tools that just coordinate work between people come inside nianav OS. The specialist tools that actually compute stay connected.
See the full stack
The connections break when people leave.
Your tools do not talk to each other. Someone is the human glue, and that person is always leaving.
See the problem
When AI does the work, who is accountable?
AI can draft the work. A named human still owns the result, with a record of exactly what happened.
See how it stays safe
Up and running in days, not months.
A guided setup proposes your system. You approve every line before your operation goes live on it.
How setup works
The audit was the work.
The evidence is created as the work happens. When the auditor arrives, the trail is already complete.
See the frameworks
Built for regulated scale-ups.
Medtech, health AI, biotech. Built by people who have done the work.
Why we built this
Every question, answered.
What it is, who it is for, what it replaces, and how AI is governed. In plain words.
Read the FAQ
One fabric. Every function.
Quality, operations, product, people, support, and finance. The same work, shown the way each team expects.
What comes insideThe product, in one picture
The same record. In every team's language.
Every tool you run is the same thing underneath: steps run over shared records. So your data is never duplicated and your evidence is always current. Click a role and watch one record change its clothes.
Nonconformance, corrective action.
Replace the tolerance check on Line 4.
Re-sign the updated procedure.
Built for the frameworks you answer to
Nobody hands you the rulebook. It's already built in.
In a regulated industry the rules are real long before anyone tells you them, and most founders meet them the expensive way, mid-audit, when a gap has already cost time and money. nianav OS knows the rulebook up front. The rules live inside the work, invisible while you operate, so the evidence an auditor asks for is produced as you go, not assembled in a scramble the week before.
Specificity is the trust signal.
More than eighty frameworks are already in the library: ISO 27001, GDPR, NIS2, ISO 14971, and the rest. Every one is already wired in; you switch on only what your scope demands, and add the next the day you need it. No rebuild, no migration. The system stays exactly as big as you are.
We are building this now
We are building nianav OS with the companies who will use it.
We are at the very beginning. If you run a medical device company heading into scale, you can help shape what this becomes, and bring two and a half decades of regulated experience into the room with you.