Structure
Turn fragmented regulatory and product knowledge into a connected model of the compliance state. Hardwire the dependencies and rules that must hold as the system grows.
For medical device teams
Structured compliance.Agentic execution.
Regulatory knowledge, product information, documentation and ongoing obligations, connected as one system for AI to operate across, with human control and provenance built in.
EU MDRDevicesEU IVDRDiagnosticsISO 13485Quality systemISO 14971RiskIEC 62304SoftwareIEC 62366UsabilityFDA QMSRUS qualityEU AI ActAI systems
Compliance, built as a connected system.
Turn regulatory requirements and company knowledge into a structured compliance system, built for AI to work across and your team to control.
Agent
Put AI to work across the system. Research, assess, write, reconcile and execute with the full regulatory and product context, continuously checked against the structure underneath.
Control & provenance
Set the boundaries for what agents can see, change and execute, and where human approval is required. Every change carries signed provenance, preserved in a cryptographic audit trail.
Solutions
Build the system. Or transform the one you have.
Build
Go from product to complete compliance system.
Bring the product context. Lumidocs determines what applies, designs how to comply, and builds the documentation and operating structure around it.
Build from scratch→Compliance Engineering
Turn existing compliance into an intelligent system.
Connect the regulatory logic already spread across your systems, documentation and teams. Then put AI to work across the whole.
Explore Compliance Engineering→Talk to us
See what Lumidocscould do for your team.
Bring us a regulatory or quality problem. We’ll show you how we’d approach it with Lumidocs.
Who you’ll talk to
Mathias StephensenFounderms@lumi-docs.com