Mid-market manufacturers and regulated businesses face the same compliance bottleneck: regulations are published as 200-page PDFs, interpreted by specialists who can't scale, and tracked in spreadsheets that are outdated the moment they're completed. CE marking alone requires mapping products to harmonized standards, assessing essential requirements, generating technical documentation, and maintaining declarations of conformity — for every product variant, every regulatory update, every market you sell into. The typical compliance department spends 60–80% of its time on documentation and evidence gathering. The actual judgment — does this product meet this requirement? — takes minutes. Everything around it takes weeks.
The EU Machinery Regulation (2023/1230), harmonized standards (EN ISO 12100, EN 61508), and your product specifications become nodes in a knowledge graph. Agents traverse this graph to determine applicability, identify requirements, and flag gaps — in seconds, not days.
When the agent checks a requirement, it generates the evidence record automatically. Technical documentation, risk assessments, conformity declarations — produced as operations run, not as a separate quarter-long project.
When a harmonized standard is revised or a new regulation takes effect, the decision logic updates. Your team gets a diff of what changed and what products are affected — not a mandate to re-read everything.
Weeks → hours per product variant
Our CE marking system structures the full conformity assessment workflow into executable agent logic.
Applicability assessment — which directives apply to your product, based on product characteristics and intended use
Harmonized standards mapping — which standards satisfy which essential requirements, with gap analysis for partially harmonized products
Risk assessment automation — structured risk assessment following EN ISO 12100 methodology, with hazard identification and risk reduction measures
Technical documentation generation — audit-ready documentation compiled from structured data, not manually assembled Word documents
Declaration of conformity — auto-generated DoC with correct legal text, applicable directives, and harmonized standards references
We'll tell you where the friction is, what should stay human, and whether automation is worth doing.