Flurina – AI Companion
Know the state of your Technical Documentation
AI-powered maturity assessment, consistency checks, and regulatory alignment across your documentation set – directly in SharePoint.
Hi! I’m Flurina Pult.
Your AI companion and expert for tech doc reviews.
Three levels of clarity
Where manual review scales linearly, with Nakamo you scale intelligently.
Level 1 – Information consistency
Do all your documents agree on the same facts?
Flurina cross-checks the most critical content for consistency. Every mismatch between IFU, DoC, CER, GSPR and PMS Plan flagged side by side.
Level 2 – MDR Completeness
Does your documentation set contain everything MDR structurally requires?
Flurina maps your full documentation set against MDR Annex II and Annex III, section by section. Finds missing documents, incomplete sections, and gaps in MDCG guidance coverage before your Notified Body does.
Level 3 – Regulatory Traceability
Does your content actually satisfy what MDR and MDCG guidance require?
Flurina checks the substance of your documentation against actual MDR requirements and MDCG guidance. Logical chains, alignment, divergence, and gaps, each classified by severity.
How it works
From Sharepoint to clarity in three steps
1. Connect your files
Just connect your Microsoft Sharepoint folder. No manual uploads. No copy-paste. Fully integrated into the Azure ecosystem.
2. Flurina runs the review
Flurina maps each document to expected MDR structure and checks presence, cross-references, and structural completeness.
3. Get a clear report
A structured analysis that shows what’s present, partial, or missing – with references to relevant MDR articles and MDCG guidance.
🇨🇭 Your data stays private. Azure-integrated and securely hosted in Switzerland.
Voices from the industry
"I measure tools by one thing: do they make the team faster without cutting corners? Nakamo does."
Thomas Bosshard
Co-CEO, Oertli Instrumente AG
“At Swiss Medtech, we see how AI will fundamentally reshape regulatory affairs in medtech. Tools like Nakamo are critical to ensure that Swiss SMEs can keep pace with increasing global requirements and remain competitive.”
Adrian Hunn
Director, Swiss Medtech
FAQ
Any questions? We’re happy to help.
Is my documentation data secure?
Yes. All processing happens inside the Microsoft Azure ecosystem. Nothing is sent to external AI providers like OpenAI. Your IP stays yours.
Do you guarantee you’ll find every issue?
No tool – human or AI – can prove it finds every issue.
Nakamo is designed to reduce blind spots by running systematic checks across your full documentation set and by showing every finding with its source so your team can verify and decide. You stay accountable, but now with stronger evidence.
What file formats do you support?
Word (.docx), Excel (.xlsx), and PDF. Documents connect through Microsoft Sharepoint: no manual uploads required.
Is this built for Startups or large manufacturers?
Both. We specifically designed Nakamo so that smaller MedTech companies without large RA teams can move as fast as the big players.
Do I get direct platform access?
We onboard customers via a guided demo to make sure the setup fits your documentation structure. No self-service guesswork. Get to know each other and book your demo call.
Which regulations does Flurina cover?
EU MDR 2017/745. Annex II, Annex III, and key MDCG guidance including MDCG 2020-6 (clinical evaluation), MDCG 2020-7/8 (PMCF), MDCG 2019-11 (software), and MDCG 2019-16 (cybersecurity). IVDR and further jurisdictions are on the roadmap.
Where is Nakamo based?
Switzerland. Our software is developed and hosted here, with full compliance to Swiss and EU data protection standards.
