Clarity at Every Step

Identify and address your most critical compliance risks with confidence at every stage. Whether you’re just launching, preparing a clinical investigation, or operating under a fully implemented QMS. LumiDocs helps you focus on the most pressing compliance tasks, while maintaining overview of the full journey ahead.

Planning
276 requirements
Compliance: 95%
Coverage: 88%
Site Selection
15 requirements
Compliance: 93%
Coverage: 80%
Submission
7 requirements
Compliance: 91%
Coverage: 75%
Initiation
93 requirements
Compliance: 60%
Coverage: 40%
Enrollment
41 requirements
Compliance: 52%
Coverage: 38%
Conduct
32 requirements
Compliance: 40%
Coverage: 30%
Closeout
89 requirements
Compliance: 20%
Coverage: 15%

Knows your
device

LumiDocs automatically analyzes your documents to deeply understand the nature of your business, devices, and clinical studies. It determines which regulatory requirements apply and how you comply efficiently.

Key CharacteristicsSelected standard: 14971

QMS-agnostic

LumiDocs works alongside your QMS by analyzing your documents and identifying non-compliance like an auditor or regulatory expert would. Direct integrations are in development and will be available on a case-by-case basis.

Document Management System
Documents
Suggestions
LumiDocs Compliance
ISO 13485
73%
ISO 14971
59%
IEC 62304
82%
Compliance Rating by Standard


Continously Adding Support for Critical Standards

ISO 13485
ISO 14155
ISO 14971
IEC 62304
IEC 62366
More Coming Soon

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Ready to get started?

Book a demo now and see how LumiDocs can streamline your compliance journey.