Flurina – AI Companion
Know the state of your Technical Documentation
AI-powered maturity assessment, consistency checks and regulatory alignment across your technical documentation.
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 every document against the MDR expected structure. It checks for presence, cross-references, and structural completeness.
3. You get a clear report
A structured report shows exactly what is present, what is partial, and what is missing, with direct references to the relevant MDR articles and MDCG guidance documents.
🇨🇭 Your data stays private and securely hosted in Switzerland.
FAQ
Any questions? Let us help you answering.
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.
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.
Where is Nakamo based?
Switzerland. Our software is developed and hosted here, with full compliance to Swiss and EU data protection standards.
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.
Which regulations does Flurina cover?
EU MDR (2017/745) and MDCG guidance. IVDR and additional jurisdictions are on the roadmap.
Which regulations and standards 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.
What file formats does Flurina support?
Word (.docx) and Excel (.xlsx), connected via Microsoft SharePoint. No uploads, no copy-paste. PDF support is on the near-term roadmap.
