Reducing regulatory burden in MedTech companies
Better medical devices benefit all of us. We support MedTech innovators bring their products faster to market with the help of our AI companions.
In use by innovative teams at
Gain insights into the maturity of your technical documentation
Know exactly where you stand, before your Notified Body does.
We check your technical documentation in three steps against the MDR framework. Three levels of documentation confidence. Each check adds depth.
You get confidence that your technical file is internally coherent and structurally submission-ready.
Review capabilities
Eliminate preventable MDR review delays
Consistency check
Verify structural integrity and cross-document consistency across your MDR technical documentation.
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MDR Completeness check
Verify if your technical documentation follows the MDR structure.
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Regulatory traceability review
Review wether the traceability structure expected under MDR is present and internally coherent.
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Gap Analysis
Compare any two versions of a regulatory norm or standard and get a reliable and accurate gap report.
Easy to get started
No software-integration or IT required
Automate the boring parts of regulatory work
Save your engineers time.
Built for small teams
No training required and no need for in-house AI or IT support.
Your data, handled with care
Technical documentation is your most sensitive IP. We treat it accordingly.
🇨🇭 Your data stays private and securely hosted in Switzerland.
Audit preparedness is not a sprint. It's an operating state.
Ready to know where you stand?
Let’s assess your actual documentation together.
Book your demoFrequently asked questions
Still got questions? Talk with the Nakamo Team to see how you can improve the quality of your gap analysis and save time.
Let's talkWhat does Nakamo and who is it for?
Nakamo builds AI companions that cut regulatory work for MedTech manufacturers. The companions check your technical documentation for consistency, completeness, and MDR traceability. Built for C-Level and QA & RA teams, from disrupting startups and lean SMEs to multi-portfolio manufacturers.
Do we need IT support to get started, and how long does setup take?
No IT support needed. Nakamo connects to your existing Microsoft SharePoint folder, no new systems, no project, no configuration. If your team can open a Word document, they are already qualified. Setup takes minutes.
How does Nakamo protect our data and documentation?
All data is processed inside Microsoft Azure. Nothing is sent to external providers like OpenAI. Your documentation never leaves your infrastructure. Developed and hosted in Switzerland, compliant with Swiss and EU data protection standards. This is architecture, not a privacy policy.
Is Nakamo built for small teams or large manufacturers?
Both. Small teams get enterprise-level documentation readiness without hiring. Larger manufacturers run structured checks across device portfolios without scaling headcount linearly.
How does Nakamo compare to a manual review by a regulatory consultant?
It is what your team does before any external consultant arrives. Flurina handles systematic cross-referencing consistency across 22 documents, Annex II structure, MDR traceability. If you then need a consultant, that person focuses on decisions, not on catching avoidable inconsistencies.
Where is Nakamo based and who is behind it?
We are based in beautiful Baden, Switzerland. The team combines Medtech expertise, UX design, and AI engineering. We are a proud member of Swiss Medtech. Whenever you are in the area, we look forward to welcoming you here in Baden for a good cup of coffee at our office.
How do we get access to the platform?
If you want to see Flurina run on your actual documentation first, we are happy to jump on a demo with you. Get to know each other and book your demo call.
What does this cost, and how do we justify the investment?
The budget question looks different once you calculate what one revision cycle after a Notified Body finding costs: in time, consultant fees, and delayed certification. Nakamo has no integration fees, no training costs, no IT project. The ROI tends to show up faster than expected.
Our manual review process already works. Why change it?
It probably does work. The question is what it costs to make it work, in hours, in senior RA capacity, and in the findings that slip through anyway. An AI companion does not get tired at document 12 of 14.
Can we trust AI in a compliance-critical environment, and what if it gets something wrong?
Fair concern. Nakamo's AI companions are built specifically for MDR technical documentation, not general-purpose tools. They run inside your own Azure infrastructure and show every finding with its source. If a finding is incorrect, your team reviews and validates before acting. You stay in control. And behind Nakamo is a team of six dedicated AI engineers, not one person figuring out how to prompt ChatGPT, whose entire job is making sure the findings are accurate.
Our regulatory processes are highly specific. Will a standard solution even fit?
Every manufacturer says this. And many manufacturers have a GSPR checklist that references an outdated CER. Nakamo's companions are built specifically for MDR - Annex II structure, MDCG guidance, cross-document consistency. These are the exact checks your Notified Body runs.
Should I trust an AI over my own team's expertise?
Correct instinct. Nakamo's companions are not here to replace your team's judgement, they make sure that judgement is spent on things that actually require it. The systematic cross-referencing that currently takes days is not where your best people should be.
What if our team becomes too dependent on the tool?
No lock-in, no API integration, no migration. Connect a SharePoint folder and run a check, once before a submission or every sprint. Nakamo fits around your process. It does not replace it.
Our vision
Support MedTech innovators bring their products to market without being held back by regulatory burden. Because better medical devices benefit all of us.
That’s why our AI companions are designed to be easy to adopt, quick to trust, and immediately helpful. No heavy integrations. No months-long rollout. Just practical, focused assistance that strengthens the teams who keep innovation moving.
