For medical device compliance

Infrastructure for
AI-driven compliance.

The bottleneck has changed

As AI transforms compliance work and auditors shift from sampled reviews to full-system analysis, generating artifacts is no longer the primary challenge. The challenge is maintaining consistency, traceability, and controlled change across increasingly complex compliance systems. At the same time, expectations rise while operators remain accountable for every claim, interpretation, and decision.

Compliance encoded structurally

Lumidocs encodes compliance and institutional knowledge structurally. Requirements, interpretations, implementations, traceability, and document content are explicitly linked and continuously validated. Consistency, redundancy analysis, change propagation, and compliance overview emerge as properties of the structure itself.

Governed human-AI collaboration

As AI operates on formalized institutional knowledge, human-AI collaboration becomes seamless and governance structural. Implementations, decisions, and interpretations remain surfaced for human review and approval. Every change is attributable and versioned, and no controlled content enters the system without explicit sign-off.

Our clinical evaluation is outdated and PMCF is missing

We need traceability from requirements through to software

I have no QMS at all and need to start from scratch

I have 13485, and need 62304

I am preparing for an MDR audit in 6 months

We have 200 procedures with a lot of redundancy

We have a partly developed 14971 risk file, but have lost track

Describe your compliance situation