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 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?
Submission readiness
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 AI with my technical documentation?
Yes, but AI should support regulatory professionals, not replace them.
Flurina identifies inconsistencies, missing references, broken traceability, and documentation drift across your technical documentation. Every finding links back to the original documents so you can review the evidence yourself. Nothing is changed automatically, and every decision remains under your control.
Does Flurina make regulatory decisions for me?
No. Flurina does not decide whether documentation is compliant or whether a submission is acceptable. It continuously monitors the structural quality, consistency, completeness, and traceability of your technical documentation, then highlights potential issues for review. Regulatory judgement and approval always remain with your team.
Our quality management and regulatory processes are highly specific. Will Flurina fit our way of working?
Yes. Our AI Companion Flurina works alongside your existing documentation and processes rather than replacing them. It reviews the relationships between requirements, risks, verification evidence, and technical documentation to detect inconsistencies as your documentation evolves. It is designed specifically for medical device manufacturers and is jurisdiction-agnostic.
How is Flurina different from a regulatory consultant?
Flurina continuously checks your technical documentation.
Instead of manually searching for inconsistencies before an internal audit, gate review, or regulatory submission, your team receives ongoing visibility into documentation quality as changes happen. Regulatory consultants can then focus on expert judgement and strategy rather than spending valuable time finding issues that could have been detected earlier.
Is our technical documentation secure?
Yes. Your documentation remains within your Microsoft Azure environment and is processed using enterprise-grade security. Nakamo is hosted in Switzerland and follows Swiss and European data protection standards. Your documents are not used to train public AI models.
Does Flurina replace our eQMS, PLM, or document management system?
No. Flurina complements your existing systems. It continuously monitors the quality and consistency of the documentation already stored in platforms such as SharePoint or Azure, helping teams detect issues without changing how they manage documents.
