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.

Schedule demo

Overview

Structured compliance dashboard

5 products
48 frameworks
Last 30 days
Export

Dependency overview

Coverage, consistency, and traceability across products, frameworks, and connected sources.

live

Frameworks

Mapped

5 products

Traceability

Review

3,412 links

Consistency

Active

742 sections

JanFebMarAprMayJun

Framework assessments

state

EU MDR

GSPR · PMS · clinical

review

ISO 13485

procedures · records

mapped

ISO 14971

risks · controls

mapped

IEC 62304

software file

review

Integrated systems

QM
PL
LM
PM
DC

Validation checks

Traceability validation

Review

47 links need confirmation

Consistency assessment

Active

31 sections flagged

Self-imposed requirements

Flagged

18 duplicate commitments

Attention queue

Clinical evidence review across 3 products
62304 alignment for 148 software items
18 duplicate release commitments

Two ways to start

Author 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.

New Documentation

Author the documentation to take your device to market.

Author technical, clinical, software, risk, usability, and quality documentation, with traceability, confirmation points, and the regulatory basis behind it.

Start authoring

Existing Systems

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.

Start monitoring

01

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

Draft scope

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

Author 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

Documents

Technical file

sections assembled

Risk mgmt file

controls traced

QMS procedure

records linked

Submission support

coverage checked

Authoring

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.

Regulatory Alignment
Guidance Alignment
Document Consistency
Redundant Commitments
Evidence Execution
Traceability Chains

Monitoring cockpit

Compliance dependencies across five products

Frameworks, guidance, documents, evidence, deadlines, and traceability chains.

Compliance alignment

review

MDR, ISO 13485, ISO 14971, IEC 62304

Guidance basis

active

Market-specific guidance attached

Evidence coverage

14 open

Tests, CER, PMS, and verification evidence

Review surface

63 active checks

Consistency

31 flags

Risk control wording differs across risk file, verification protocol, and IFU draft.

Redundancy

18 items

Two SOPs create separate supplier-review intervals for the same critical supplier class.

Evidence

14 open

Verification evidence missing for requirements linked to risk controls.

Traceability chains

Design control

96%

input → output → verification → validation

Risk control

review

hazard → control → verification

PMS/CAPA

active

complaint → trend → CAPA

Regulatory dates

PMS / PSUR evidence cutoff

Jun 18

Critical supplier review due

Jun 25

CAPA effectiveness evidence

Jul 03

Founders

Mathias & Niklas — We spent time in medtech and watched compliance work happen the same way everywhere: documents in disconnected silos, knowledge locked in the heads of a few experts.

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.

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