Lumidocs
Lumidocs provides a structured compliance platform for medical device teams, translating regulatory frameworks like ISO 13485, ISO 14971, and EU MDR into a connected system of obligations, decisions, and traceable artifacts. The platform uses AI agents to author documentation, monitor dependencies, and assess change impact, with human control and cryptographic provenance built in. It ingests existing quality systems and offers live registers resolved directly from the compliance state.
- Regulatory & Compliance Technology
- AI Agents
- Artificial Intelligence
- Software Only
- Hardware
- Healthcare Technology
- Medical Devices
Funding
Founders
Founder details are not available yet.
Product
Problem
Medical device compliance teams manage documentation across disconnected silos, with regulatory knowledge scattered in spreadsheets, Word files, and the memory of individual experts. Every audit becomes a manual archaeology project, and understanding what a change to one procedure or product specification will affect requires time-consuming cross-referencing across isolated sources.
Solution
Lumidocs structures compliance as a connected system rather than a collection of documents. The platform translates regulatory frameworks like ISO 13485, ISO 14971, IEC 62304, EU MDR, and FDA guidance into obligations, decisions, specifications, artifacts, traceability, and checks. Teams can author technical, clinical, software, and quality documentation from this structured source, with every section linked back to its regulatory basis, confirmed inputs, and traceable dependencies. Lumidocs also ingests existing quality systems, reconciles scattered records, and continuously monitors dependencies across procedures, training, product data, and evidence, surfacing what needs review when anything changes. The platform provides impact previews that show what a modification to a procedure, test protocol, supplier, or market addition will affect before the change is made.
Target Audience
Primary customers are medical device companies, including startups and established organizations, that need to manage regulatory compliance documentation across quality, risk, software, usability, clinical, and post-market surveillance areas. The platform serves teams preparing for EU MDR/IVDR submissions, FDA clearances, or maintaining existing quality systems.
Features
- Framework translation engine that converts standards like ISO 13485, ISO 14971, IEC 62304, EU MDR, IVDR, and FDA QMSR into structured obligations, decisions, specifications, artifacts, traceability, and checks
- AI agents that plan, investigate, draft, assess, reconcile, and execute compliance work with full regulatory and product context continuously checked against the underlying structure
- Dependency monitoring that tracks relationships across procedures, records, training, product data, evidence, and regulatory interpretations
- Change impact analysis that shows what a modification to a procedure, test protocol, supplier, or market addition will affect before the change is made
- Ingestion and reconciliation of existing quality systems, including partial technical files, spreadsheets, supplier records, claims, controls, and prior submissions
- Control and provenance layer where every material input, output, and change retains source, actor, history, and signed provenance in a cryptographic audit trail
- Self-imposed requirement detection that flags duplicate commitments, repeated controls, and parallel processes
- Live registers resolved directly from the compliance state, including applicability, coverage, traceability, and document registers
- Export capabilities for PDF or Markdown documents while maintaining the same structured source of truth
- Framework-specific output modules for quality systems, design controls, FDA market access, risk management, software lifecycle, cybersecurity, usability engineering, clinical evidence, and biological safety