LumiDocs

The Platform

Weeks of compliance work.
Done in hours.

Upload your documentation. See exactly where you stand across MDR, ISO 13485, FDA QSR, and 40+ frameworks. Generate compliant documents with full traceability.

Book demo
30+
Gap types identified
100%
Traceability coverage
40+
Frameworks supported
Doctor with patient

Our belief

Compliance should be about patient safety.
Not manual paperwork.

We build tools that help MedTech teams move faster while maintaining the rigor that patient safety demands.

How it works

01 — Gap Analysis

See every gap across 40+ frameworks. Instantly.

Upload your documentation. Get a complete gap analysis across MDR, ISO 13485, FDA QSR, and more — in minutes, not weeks.

Review against all frameworks at once

MDR, ISO 13485, IEC 62304, FDA QSR, ISO 14971, IEC 62366 — analyzed simultaneously.

→ No more framework-by-framework reviews

See exactly what's missing

30+ gap types identified: missing documents, incomplete sections, broken traceability, missing evidence.

→ No ambiguity in what needs fixing

Drill down to the source

Every gap traces from framework overview → specific clause → exact supporting documentation.

→ Full transparency on every finding

Understand why it matters

Gaps prioritized by severity. Critical issues surface first. Clear impact assessment.

→ Fix what matters most, first

Get remediation guidance

Actionable recommendations aligned with FDA guidance, MDCG best practices, and industry standards.

→ From gap to resolution in seconds

Full audit trail

Trace every score, every gap, every recommendation back to the exact document, page, and passage.

→ Complete explainability for auditors
See all 40+ frameworks →
02 — Documentation

Your decisions drive the documentation.

AI understands your regulatory context, drafts compliant documents, maps them across frameworks, and keeps everything audit-ready.

Tailored to your regulatory context

Before writing a single word, LumiDocs synthesizes your product classification, target markets, and applicable frameworks to tailor every recommendation.

MDR 2017/745
Annex II
MDCG 2019-16
Guidance
ISO 13485
§7.3
Your Context
Class IIa
Tailored Recommendation
For your Class IIa cardiovascular device, establish 3 design review gates with verification checkpoints aligned to MDR Annex II §4.1. Include risk-based acceptance criteria per ISO 14971...
Accept & Apply
Modify
Decision Accepted
Implement gate-based design review with verification checkpoints aligned to MDR Annex II §4.1
SOP-DES-001
§4.2 Design Review Gates
Drafted
DHF-001
§3.1 Design Planning
Drafted
TF-001
§4.1 Verification
Drafted

From decisions to drafts, instantly

Every decision you approve triggers intelligent drafting across all affected documents — written by AI agents with full regulatory context.

Built for multi-framework compliance

One document can serve any number of frameworks, with clauses mapped to specific paragraphs.

SOP-DES-001
Design & Development
4.2.1
Design reviews shall be conducted at defined stages to evaluate the ability of the design to meet requirements...
MDR Annex II §4.1FDA 820.30(e)
4.2.2
Review participants shall include representatives of functions concerned with the design stage being reviewed...
ISO 7.3.4FDA 820.30(e)
4.3.1
Design inputs relating to the product shall be documented and include functional, performance, and safety requirements...
MDR Annex II §4.2ISO 7.3.3UK Sch 2 §4
Add FDA 21 CFR 820
US market expansion
347 requirements
Impact Analysis Complete
118
docs affected
76
new docs needed
68%
already covered
194 gaps identified across QMS
View all →

Evolve without breaking

Regulations change. Products evolve. Your documentation stays mapped — instantly surfacing gaps and propagating updates for consistency.

Instantly ready for audit

Compliance tables generate automatically — always current, always complete.

ISO 13485:2016 Compliance Matrix100% coverage
ClauseRequirementEvidence
4.2.4Control of Documents
QMS-001SOP-DOC-001
7.1Planning of Product Realization
QMS-012SOP-DES-001
7.3.2Design and Development Planning
SOP-DES-001DHF-001
7.3.4Design and Development Review
DHF-001DHF-004
7.3.6Design and Development Validation
DHF-001TF-002
7.5.1Control of Production
SOP-PRD-001WI-001
03 — Traceability

Audit-ready traceability. Always.

From user needs to test results — every link established, every connection validated for logical coherence.

Before

Manual matrices. Scattered systems.

Traceability lives in spreadsheets, Jira, and documents. Links are manually maintained. Regulatory alignment is verified through time-consuming document-by-document review.

Traceability_Matrix_v23_FINAL.xlsx
A
B
C
D
1
Input
Output
Test
Status
2
DI-001
DO-001
TC-001
OK
3
DI-002
?
TC-002
?
4
DI-003
DO-003
see jira
OK?
5
DI-004
DO-004
-
TBD
6
DI-005
??
TC-005
-
With LumiDocs

One connected system. Always validated.

Every traceable item is governed by rules extracted from your regulatory frameworks. AI creates items and links as you work — you approve. Every node is checked for compliance, every edge for logical coherence.

Change a single item — the entire chain revalidates automatically.

See what's traced by framework
User NeedUN-001Design InputDI-047Design OutputDO-023Risk AnalysisRA-012VerificationVER-089!ValidationVAL-056Test ProtocolTP-134Test ResultsTR-098CAPACA-067
Coherence Issue Detected
User Need UN-001 specifies "operate at 2-8°C" but linked verification VER-089 tests at 20°C ambient
Review LinkDismiss
04 — AutomationComing Soon

Automation that delivers. Precision you can measure.

Agentic SOP Execution

AI agents execute your standard operating procedures autonomously — collecting data, updating records, triggering workflows across your business tools.

Executes multi-step procedures end-to-end
Integrates with your existing tools
Human approval gates where you need them
Full audit trail for every action

Repeatable QA Workflows

Automate predictable quality processes with guaranteed ROI. Every workflow is measurable, with ongoing precision validation against human-verified samples.

Guaranteed, measurable ROI
Continuous precision validation
Benchmarked against human samples
Consistent execution every time

Be the first to automate your QA processes with precision and control.

Join the waitlist