LumiDocs

Regulatory Intelligence for MedTech

Compliance,
reimagined.

LumiDocs brings clarity to regulatory complexity. Surface gaps instantly, generate documentation from decisions, and maintain traceability automatically.

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40+ regulatory frameworks

Compliance for patient safety.
Not paperwork.

01

Gap Analysis

Select your frameworks. All gaps surfaced.

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02

Documentation

Define your product and business. Regulatory documents follow.

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03

Traceability

Validated end-to-end, continuously.

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04Soon

Automation

Automate any procedure across your tools.

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Development team at work

Built for MedTech teams

Manufacturers

Manufacturers

Scale your portfolio without scaling your regulatory team.

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Consultants

Consultants

Handle more engagements with templates at AI scale.

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Enterprise

Enterprise

On-premise deployment with verifiable compliance.

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Comprehensive Coverage

40+ regulatory frameworks. Always current.

From FDA to MDR, ISO to IEC. Every framework continuously updated as regulations evolve.

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