Check technical documentation for MDR compliance using Nakamo’s regulatory AI
Inconsistencies, gaps and a lack of traceability in technical documentation sometimes only come to light when the notified body identifies them. Nakamo’s AI companion “Flurina” systematically checks your documentation before it becomes a problem.
An AI Companion team for medtech manufacturers: Review technical documentation. Identify gaps. Submit with confidence.
C-level, QA and RA teams in the medical technology sector are working under increasing pressure. The MDR sets high standards, and most audits paint the same picture: inconsistencies between documents, a lack of traceability, and gaps that only become apparent when a notified body identifies them. Nakamo highlights these risks before your next audit.
What “Flurina” does
Flurina is Nakamo’s latest Regulatory AI Companion. It connects to your existing SharePoint environment. It then reads your technical documentation and performs three targeted checks:
- 1. Consistency: Does identical information match across all documents?
- 2. Completeness: Are all required MDR documents present and sufficiently populated?
- 3. Regulatory traceability: Can your GSPR requirements be traced through clinical and risk documentation?
Every finding is displayed with the source document and reference. No black box. No guesswork.
Who benefits
Medical device manufacturers preparing their technical documentation for MDR approval, or who have already submitted it and are updating it on an ongoing basis. Teams looking to reduce manual cross-references and shorten submission cycles. Companies that need to know where they stand ahead of a gate review or an audit.
Nakamo at MedtecLIVE 2026
Come by and see Flurina in action, working on technical documentation with real-world findings.
Further information can be found on our website or our LinkedIn page.
