Build from scratch

Build compliance as a system from day one.

Use AI to research requirements, make regulatory decisions, generate technical, clinical and quality documentation, build traceability matrices and prepare evidence, while every step builds the structured compliance state underneath.

  • Plan
  • Write
  • Trace
  • Assess
  • Control
  • Operate
Build with Lumidocs

02Build with Lumidocs

Build the complete compliance system.

  1. 01Plan

    Know what you need.

    Determine what applies, research how to comply, and build the plans and expected artefacts for your product and markets.

    • Applicability
    • Research
    • Plans
    • Artefacts
    • Markets

  2. 02Write

    Write every document you need.

    Generate technical, clinical and quality documentation from regulatory requirements, product information and the decisions already made.

    • Plans
    • Reports
    • Specifications
    • Manuals
    • Procedures
    • Technical
    • Clinical
    • Quality

  3. 03Controlled documents

    Documents that stay controlled.

    Identifiers, revisions, status, effective dates, approvals and revision history are served from the underlying state rather than maintained by hand inside files.

    • Identity
    • Version
    • Status
    • Effective date
    • Approval
    • History

  4. 04Traceability

    Build and validate traceability.

    Build traceability matrices across requirements, risks, controls, design and evidence, then continuously validate them against activated rules.

    • Coverage
    • Relationships
    • Wording
    • Validation
    • Revalidation

  5. 05Assessment

    Assess continuously.

    Continuously assess against applicable frameworks, endorsed guidance and established best practice, including cross-document consistency and redundancy.

    • Frameworks
    • Guidance
    • Best practice
    • Consistency
    • Redundancy

  6. 06Control & provenance

    Nothing gets approved by accident.

    Every material input, output and change retains its source, actor, history and provenance. AI-generated content stays identified and cannot enter an approved state without controlled human review.

    • Sources
    • Attribution
    • History
    • Authority
    • Human review

  7. 07Live registers

    Registers that stay current.

    Applicability, requirement coverage, traceability and document registers are resolved directly from the compliance state rather than maintained separately.

    • Applicability
    • Coverage
    • Traceability
    • Documents

  8. 08Agents

    Work across the whole system.

    Use agents to plan, investigate, draft, assess, reconcile and execute, with regulatory requirements, product context, evidence, documents and prior decisions already in context.

    • Plan
    • Investigate
    • Draft
    • Assess
    • Reconcile
    • Execute

Coming soon

  1. 09Operations

    Turn compliance into operations.

    Convert the compliance state into the operating model that keeps it true: deadlines, responsibilities, training requirements, recurring obligations and change-triggered work.

    • Deadlines
    • Responsibilities
    • Training
    • Triggers
    • Recurring work
    • Execution

  2. 10QMS

    Run the QMS in Lumidocs.

    The table stakes required to operate Lumidocs as the quality management system itself: document control, electronic signatures, training, records, workflows and administrative controls.

    • Document control
    • E-signatures
    • Training
    • Records
    • Workflows
    • Administration

03Built as you go

The work builds the system.

Lumidocs does not generate isolated compliance documents. As you plan, decide, write and gather evidence, the regulatory meaning underneath the work is captured with it.

Requirements connect to the decisions for how you will comply. Decisions connect to product facts and risks. Content connects to what it implements. Evidence connects to what it demonstrates.

By the time the documentation is built, the compliance system exists underneath it.

Traceability

Design Control · Device XExport
Open findingsCritical 0Major 1Minor 0Coverage80 %Item QC4 / 5 pass
CodeItemTraces toAssessmentBy
User need1 item · stage assessment ranClean
UN-002Blood-oxygen (SpO₂) display→ DI-002PassAI
Design input2 items · 1 finding1 major
DI-002SpO₂ accuracy ± 2 %→ DO-002PassAI
DI-003Device weight · no acceptance threshold—1 issueAI
Design output1 item · stage assessment ranClean
DO-002SpO₂ algorithm specIn review→ VP-002PassAI
Design verification1 item · stage assessment ranClean
VP-002SpO₂ accuracy test protocol→ VAL-001PassAI
Design validation1 item · not yet runNot assessed
VAL-001Clinical accuracy studyDraft——YOU

6 items4 trace links4 / 5 pass1 findinglast exported Design Control Matrix.xlsx

04Continuous control

Keep the whole system true.

Once the relationships are explicit, Lumidocs knows what should remain true as the system changes.

A product fact changes and the dependent decisions, risks, claims and content can be reassessed. A requirement changes and its implementation and evidence can be checked again. A document changes and consistency and traceability revalidate.

Known relationships determine what to check. AI handles the judgment required to check them.

Provisions

ScopeDevice XISO 13485:2016Needs review3

Open findings

  • Critical0
  • Major3
  • Minor0
  • Inconsistent1
  • Not built yet2
  • Recommendation1

Waiting on you

  • Plans1
  • Decisions1
  • Requests1
RefRequirementStateMeans of complianceImplemented inNext action

ISO 13485 · 4 Quality management system

4.2.3Medical device fileLiveEN ISO 13485Quality Manual+1+ Plan
4.2.4Control of documentsLive11EN ISO 13485Document Control SOP+ Address

ISO 13485 · 7 Product realization

7.3.3Design and development inputsLive1EN ISO 14971Design & Development SOP+1+ Address
7.3.6Design and development verificationPending reviewIEC 62304Design Control Matrix+1+ Execute
7.3.9Control of design and development changesNeeds plan1MDCG 2020-3None yet+ Plan

ISO 13485 · 8 Measurement, analysis and improvement

8.2.2Complaint handlingWorking11MDCG 2023-3None yet+ Address
8.5.2Corrective actionLive1EN ISO 13485CAPA Process+ Execute

7 provisions · 7 open findingsEvery tile above is the marks below summed

Documents7

2not syncing3inconsistent1awaiting reviewSharePoint
NameStatusSyncConsistencyProvenance

Quality Manual1

Quality Manual.docxApproved1YOU

Procedures (SOPs)3

Design & Development SOP.docxApprovedAI
CAPA Process.docxIn reviewPaused2YOU
Document Control SOP.docxDraftYOU

Design Control3

Design Control Matrix.xlsxlive · traceabilityApprovedAI
Product Specification v2.1.docxApprovedPaused1YOU
Design review minutes · gate 2.docxDraft——AI

7 documents in 3 foldersFolders mirror the connected SharePoint drive

05Where it goes

Build it. Then run it.

The compliance state built during development is also the foundation for operating it: obligations, deadlines, responsibilities, training and recurring work can become explicit parts of the same system.

  1. BuildRequirements → Decisions → Documents → Evidence
  2. MaintainAssessments → Traceability → Controls → Change
  3. Operatecoming soonObligations → Deadlines → Training → Execution
  4. QMScoming soonRecords → Workflows → Signatures → System of record
Already have an established Regulatory & Quality operation?See how Lumidocs works across existing systems, documentation and organisational knowledge.Compliance Engineering

Talk to us

Build the systemfrom the beginning.

Bring us the product, the regulatory ambition and what you already know. Build the compliance system around it.

Who you’ll talk to

Mathias StephensenFounderms@lumi-docs.com