For Medical Devices
Turn document-based compliance into a system.
Compliance is not a collection of disconnected documents. Lumidocs structures the frameworks, decisions, evidence, controls, and dependencies behind them, so teams can build documentation and understand what changes next.
Overview
Structured compliance dashboard
Dependency overview
Coverage, consistency, and traceability across products, frameworks, and connected sources.
Frameworks
Mapped
5 products
Traceability
Review
3,412 links
Consistency
Active
742 sections
Framework assessments
state
EU MDR
GSPR · PMS · clinical
ISO 13485
procedures · records
ISO 14971
risks · controls
IEC 62304
software file
Integrated systems
QMS
Procedures
PLM
Product data
LMS
Training
PMS
Signals
Docs
Content
Validation checks
Traceability validation
Review47 links need confirmation
Consistency assessment
Active31 sections flagged
Self-imposed requirements
Flagged18 duplicate commitments
Attention queue
Two ways to start
Build what you need now, or monitor what already exists.
Build the documentation required to move a device toward market, or connect an existing quality system so dependencies, records, and change impact stay visible. Both paths start from the same structured model.
Startup
Get the material needed to take your device to market.
Receive authored technical, clinical, software, risk, usability, and quality documentation with traceability, confirmation points, and the regulatory basis behind it.
Build my compliance packageSME / Enterprise
Wire up existing systems for monitored overview.
Connect existing documents, records, product data, QMS, PLM, LMS, and post-market sources to monitor dependencies, consistency, traceability, and change impact.
Monitor my compliance system01
Start with the frameworks your device requires
ISO 13485, ISO 14971, IEC 62304, MDR, FDA context, and more are translated into obligations, decisions, specifications, artifacts, traceability, and checks. The standards become execution structure, not a pile of disconnected clauses.
Supported frameworks
Quality, risk, software, usability, clinical, labeling, PMS, FDA, and EU contexts
Connected obligations
Requirements linked to decisions, evidence, records, training, and artifacts
Inspectable basis
Guidance, source context, best-practice research, and open confirmations remain visible
Framework plan
SaMD, Class IIa, EU + US
Device profile
Cloud software supporting clinical decisions
Professional users, EU + US launch, software lifecycle and risk controls required.
Frameworks
ISO 13485
QMS
ISO 14971
risk
IEC 62304
software
IEC 62366-1
usability
EU MDR
technical file
FDA
design controls
Implementation plan and confirmation points generated from the selected profile.
Obligations
mapped
Artifacts
planned
Confirmations
surfaced
Basis
attached
02
Build documentation from structure
Technical, clinical, software, risk, and quality documentation can be assembled from the same approved source.
Outputs carry their basis: requirements, decisions, specifications, traceability, and open confirmation points.
Structured source
Obligations
Decisions
Product data
Evidence
Assembly
Authored from one structure
coverage
checked
traceability
checked
cross-reference
checked
Deliverables
Technical file
sections assembled
Risk mgmt file
controls traced
QMS procedure
records linked
Submission support
coverage checked
Authored deliverables
Documents are authored from approved context, with their requirements, decisions, and traceability still visible.
No duplicated facts
Tables, matrices, cross-references, and repeated product data render from structured source.
Traceability
Requirements, controls, evidence, records, training, and document sections stay connected.
03
Monitor the system behind the documents
Procedures, records, product data, evidence, training, and post-market signals keep moving after the first delivery.
Lumidocs monitors the relationships between them, so coherence, redundancy, evidence gaps, traceability drift, and change impact surface before they become detective work.
Proposed change
Can Product B add home use?
Add patient and caregiver use outside clinical settings for one released product family in the EU and US.
Review queue
Live
IFU / labeling
patient and caregiver language
Risk file
use-error and alarm scenarios
Usability file
lay-user validation scope
Clinical evaluation
evidence for home-use claims
PMS plan
home-use signal categories
Training items
caregiver and support workflow
Founders
Mathias & Niklas — We spent time in medtech and watched compliance work happen the same way everywhere: documents in disconnected silos, knowledge in the heads of a few experts or in a consultant's Dropbox.
The gap isn't that regulated teams work slowly. It's that the tools weren't built for this work.
Lumidocs is the system we wanted to use.