For Quality & Regulatory
More judgement.
Less cross-referencing.
Our solution handles the systematic monitoring across your technical documentation. Your experts spend their time on the calls that need a human.
The real problem
You are personally accountable for the file.
If it is inconsistent or incomplete, you are the one who pays. Audits and Notified Body reviews can land any time, so you need to be ready all the time. You spend your days cross-referencing documents by hand instead of using your regulatory judgement. You find the inconsistency too late, right before a submission or an audit.
Our solution
Our AI companion Flurina covers what your team does before any external consultant arrives.
Cross-document consistency, structure, and traceability, every finding shown with its source. You review and validate. You stay in control. It augments your judgement, it does not replace it. You get a sourced, defensible finding list, not a black-box verdict.
The test you can run today
Take your last closed change. Trace it. Was every linked document, risk control, and protocol actually updated, or did one slip? The one that slipped is tomorrow's audit finding.
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On trust and your data
This matters most for you, because you are the one who signs. Every finding is sourced and reviewable, so you can defend it. Nothing is applied without you. The data stays in Microsoft Azure. The AI flags, you decide.
Where our solution makes the difference.
Change Control
When you close a change, are you certain every affected document was actually updated?
New Harmonised Standard
A standard just got revised. Can you list every document in your file that references the old version?
Before Submission
No more surprises at document 12 of 14.
Gate Review
What if gate prep took thirty minutes instead of a week?
Voices from the industry
"Working with Nakamo's AI Companion has significantly changed how we create and conduct gap analyses. The analyses are precise, the outcomes are immediately actionable, and the tool saves us a considerable amount of time, allowing us to focus on tasks that truly require human expertise."
FAQ
Any questions? We’re happy to help.
Can I trust an AI with the file I have to sign?
Every finding is sourced and reviewable, so you can defend it. Nothing is applied without you. You stay in control.
Will it take decisions I am accountable for?
No. It flags, you decide. The accountability and the judgement stay with you.
Our regulatory processes are highly specific. Will a standard solution fit?
Our solution is built for MDR, Annex II structure, MDCG guidance, and cross-document consistency. These are the exact checks your Notified Body runs.
How does it compare to a regulatory consultant?
It is what your team does before a consultant arrives. The consultant then spends time on decisions, not on catching avoidable inconsistencies.
Is our data safe?
Processed inside Microsoft Azure, nothing sent outside, hosted in Switzerland under Swiss and EU standards.
