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Platform · LuminLogic IQ

Intelligence where work happens.

Transform expertise into action. LuminLogic IQ converts Regulatory Intelligence into practical operational guidance across quality, regulatory, engineering, and business activities. Rather than a standalone AI tool, it works directly within regulated workflows, providing recommendations, summaries, analysis, prioritization, and decision support where work actually happens.

IQ · live
luminlogic.appLuminLogic IQ, root cause analysis assistance on a CAPA
Grounded in25+ years of MethodSense expertise
EngineLuminLogic IQ
DeliveredInside the workflow
Intelligence where work happens

IQ, embedded in the record.

Summaries, root-cause drafts, gap analysis, and reportability decisions: generated inside regulated workflows, with every interaction logged next to the record it touched.

luminlogic.appLuminLogic IQ command palette
Why most AI tools fall short

AI without context creates risk.

Many AI systems generate responses without understanding the regulatory, quality, operational, or business context behind the question. Regulated organizations require intelligence that understands workflows, traceability, compliance requirements, and operational objectives. LuminLogic IQ operates within that context.

Generic AI
  • Limited workflow awareness
  • Limited traceability
  • Generic recommendations
  • Separate from operations
LuminLogic IQ
  • Workflow aware
  • Regulatory informed
  • Operationally connected
  • Traceable and auditable
Intelligence throughout the platform

Embedded throughout the operational environment.

LuminLogic IQ supports activities across the platform rather than existing as a separate destination.

Document summaries

Understand complex content quickly and efficiently.

Complaint evaluation

Support consistent assessment and review activities.

CAPA analysis

Accelerate investigations and corrective action planning.

Gap assessments

Identify potential weaknesses and improvement opportunities.

Workflow recommendations

Guide users toward appropriate next actions.

Operational insights

Surface trends and priorities across activities.

Accelerate quality operations

Move from information to action faster.

Quality teams spend significant time reviewing documents, evaluating issues, managing investigations, and coordinating actions. LuminLogic IQ reduces manual effort by organizing information, highlighting priorities, and supporting decision-making throughout the process.

Faster reviews

Reduce time spent analyzing information.

Better prioritization

Focus attention on what matters most.

Improved consistency

Apply common evaluation approaches.

Greater visibility

Understand operational trends more quickly.

CAPA · CAPA-2026-044 · IQ assist
DetailsIQHistory
IQ · reading this CAPA
Suggested root cause
Torque variance at Step 7 of bonding sub-assembly, traced to receiving inspection of supplier batch 24-118.
Suggested next step
Route to Quality lead · attach effectiveness verification plan · link to SCAR-019.
Cited from
47 closed CAPAs · ISO 13485 §8.5 · 21 CFR §820.100.
Apply to record →
Accelerate regulatory operations

Support regulatory decision-making.

Regulatory activities often involve large volumes of documentation, evolving requirements, and complex decision paths. LuminLogic IQ helps organize information, surface relevant insights, and maintain visibility across regulatory activities.

Submissions · 510(k) K###### · IQ
ReadinessSources
IQ · submission readiness
Section coverage
Device description, intended use, and biocompat complete; 3 sections drafted.
Flagged gaps
IEC 60601-1 §15.4 mechanical-strength evidence marked TBD, not invented.
Linked sources
Every paragraph traced to its DDF record for reviewer sign-off.
  1. 01

    Submission preparation

    Support document readiness and coordination.

  2. 02

    Regulatory reviews

    Identify key information more efficiently.

  3. 03

    Compliance monitoring

    Maintain awareness of operational priorities.

  4. 04

    Readiness assessments

    Evaluate status across activities.

Regulatory Intelligence

Built on expertise, not just algorithms.

LuminLogic IQ derives its value from the Regulatory Intelligence foundation that powers the platform. The knowledge, experience, and best practices developed through decades of regulatory and quality work provide the context that makes recommendations more relevant and actionable.

IQ · live
Complaint · CMP-2026-118 · IQ assist
DetailsIQHistory
IQ · reading the record
Suggested classification
Non-reportable per MDR criteria, no malfunction, no patient harm indicated.
Suggested action
Open trend review, 3rd similar complaint on lot 24-118 this quarter.
Cited from
MDR 21 CFR §803 · 6 prior complaint dispositions · linked CAPA-2026-044.
Apply to record →
Grounded in25+ years of MethodSense expertise
EngineLuminLogic IQ
DeliveredInside the workflow
Trust, governance, and control

Built for regulated environments.

Intelligence must operate within the controls expected by regulated organizations. LuminLogic IQ is designed to support governance, traceability, accountability, and transparency throughout operational activities.

Traceability

Maintain visibility into actions and outcomes.

Accountability

Support role-based responsibility.

Auditability

Preserve historical records and context.

Transparency

Provide visibility into recommendations and activities.

Control

Align intelligence with established processes.

Customer outcomes

The value of operational intelligence.

Faster execution

Reduce time spent gathering and evaluating information.

Better decisions

Support actions with context-aware recommendations.

Improved productivity

Focus on execution instead of administration.

Increased visibility

Surface operational insights across the organization.

Stronger consistency

Apply knowledge and best practices more broadly.

Greater confidence

Support quality and regulatory activities with trusted guidance.

The future of regulated operations

From systems of record to systems of intelligence.

The future of quality and regulatory operations depends on more than storing information. Organizations need systems that understand context, support decisions, and help teams execute more effectively. LuminLogic IQ represents the next step in that evolution.

YesterdayRecords
TodayWorkflows
NowIntelligence
Intelligence where work happens

Experience LuminLogic IQ.

See how LuminLogic IQ transforms Regulatory Intelligence into practical operational guidance that accelerates execution, improves visibility, and supports better decisions across the product lifecycle.