Nakamo
Nakamo provides AI companions for MedTech manufacturers to automate technical documentation review. Its AI companion, Flurina, continuously monitors documentation within existing file systems like SharePoint, checking for consistency, completeness, and traceability, and flagging every finding with its source. This helps teams maintain audit readiness and reduce preventable delays before Notified Body reviews.
- Regulatory & Compliance Technology
- Artificial Intelligence
- AI Agents
- Software Only
Funding
Founders
Founder details are not available yet.
Product
Problem
MedTech manufacturers face substantial administrative burdens from technical documentation, which consumes engineering time and delays product launches. Manual checks for consistency, completeness, and traceability across complex technical files are error-prone, and teams often discover compliance gaps only during costly audits.
Solution
Nakamo offers AI companions, including "Flurina," that continuously monitor technical documentation within a manufacturer's existing file system. Flurina performs systematic cross-checks for consistency, completeness, and traceability, flagging every finding with its source and alerting teams the moment something changes. This allows companies to know exactly where their documentation stands at all times, before a Notified Body reviews it, reducing preventable audit delays and freeing up engineering time for product development.
Target Audience
Primary users are MedTech manufacturers, from lean start-ups to multi-portfolio companies, specifically the engineers, regulatory teams, and product managers responsible for product quality and audit readiness.
Features
- Continuous monitoring of technical documentation for internal coherence and structural submission-readiness
- Change impact analysis to visualize the "blast radius" of any modification across the entire technical file
- Cross-document consistency checks to catch contradictory statements across documents
- Traceability review verifying that requirements, risks, and tests are properly linked
- Every finding is sourced with a reference, avoiding a "black box" AI output
- Works with existing file systems (e.g., SharePoint) with no migration, API integration, or IT project required
- Data processed within Microsoft Azure and hosted in Switzerland, ensuring IP privacy