Lumidocs is a compliance platform that transforms document-based medical device quality systems into structured, interconnected data. It models regulatory frameworks, decisions, evidence, and traceability so teams can author documentation and understand the downstream impact of any change. The platform supports EU MDR, ISO 13485, IEC 62304, and other key standards.
Funding
Funding not disclosed
Founders
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.
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 and guidance into structured obligations, decisions, specifications, artifacts, traceability, and checks
- Authoring surface where every document section carries its basis, including framework scope, guidance context, confirmed specifications, and open confirmation points
- 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, and prior submissions
- Export capabilities for PDF or Markdown documents while maintaining the same structured source of truth
- Support for multiple frameworks including EU MDR, IVDR, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, and FDA design controls
- Self-imposed requirement detection that flags duplicate commitments, repeated controls, and parallel processes