Start with the question your team needs to answer.
Investigate complaint increases, product changes, affected lots, supplier issues, fragmented evidence, suspected causes, and missing information across systems.
Investigate with MDARIX
Why did complaints increase after Rev B?
Follow a signal through product version, change, component, supplier, lots, evidence, hypotheses, unknowns, assurance, and human decision.
Complaint signal
Product version
Change
Component
Supplier
Affected lots
Evidence
Hypotheses
Contradictions
Unknowns
Assurance
Human decision
Solutions
By challenge
Investigate Complaint Increases
Understand what is driving an increase in complaints.
A rise in complaints may relate to a product version, component, supplier, lot, market, or change. MDARIX helps teams review these connections in context, explore possible patterns, and document the evidence behind their assessment.
Connect complaint patterns to product versions, changes, components, suppliers, lots, and evidence so investigators can separate a signal from a conclusion.
Understand Product Changes
See how product changes relate to field experience.
Design, component, supplier, software, and manufacturing changes can affect products already in use. MDARIX connects change history with product context and post-market signals to help teams assess possible relationships.
Compare product revisions and controlled changes with complaint timing, affected lots, configuration, and supporting evidence.
Find Affected Products & Lots
Map potential impact across products and lots.
When an issue is identified, teams need to understand which products, versions, configurations, or lots may be involved. MDARIX connects these records to organize scope assessment and review supporting relationships.
Follow product versions, component relationships, suppliers, and lot context to identify what is affected and what remains unknown.
Investigate Supplier Issues
Follow supplier relationships through to product impact.
Supplier-related issues can affect multiple components, products, and lots. MDARIX connects supplier records with product and post-market context to support a complete review of potential impact.
Bring supplier, component, change, lot, and complaint relationships into one investigation workspace.
Connect Fragmented Evidence
Bring scattered evidence into the decision context.
Relevant information can be spread across quality, regulatory, product, supplier, and manufacturing systems. MDARIX connects available records to the issue under review and makes missing evidence visible.
Review source anchors, reliability, temporal context, contradictions, and missing evidence before forming a hypothesis.
Challenge Suspected Root Causes
Test suspected causes against connected evidence.
A plausible cause should be evaluated against available facts and alternative explanations. MDARIX organizes hypotheses, supporting or conflicting evidence, and uncertainty before a conclusion.
Expose competing hypotheses, contradictions, unknowns, and limitations so authorized humans can review the reasoning.
Identify Missing Evidence
Make evidence gaps visible before decisions are finalized.
MDARIX identifies missing, outdated, or conflicting evidence links so reviewers understand what is known, what remains uncertain, and what still needs attention.
Surface incomplete traceability, missing lot references, unsupported failure chains, and other evidence gaps.
Solutions
By role
Quality Leaders
Give quality leaders the full investigation picture.
Review product reality, evidence quality, competing explanations, assurance, and human decisions in one governed view.
Investigators / QA
Move from signal to evidence with confidence.
Build a traceable investigation across product, change, supplier, lot, complaint, evidence, and hypothesis context.
Regulatory Affairs
Prepare traceable review context.
Preserve provenance, limitations, temporal context, and human review boundaries for regulated investigation workflows.
Product / R&D
Connect product changes to outcomes.
Understand how revisions, components, configuration, and lifecycle events relate to downstream signals.
Supplier Quality
Follow supplier and component relationships.
Investigate supplier-linked signals with affected lots, component revisions, evidence, and missing context in view.
Manufacturing Quality
Understand affected lots and changes.
Connect manufacturing context to product versions, lots, complaints, evidence, and investigation decisions.
Executives
Review decision-ready assurance.
See what is known, what is challenged, what remains unresolved, and where human authorization is required.
Solutions
By investigation
Complaint Investigation
Understand the signal before deciding what changed.
Connect complaint patterns to product versions, field reports, affected lots, and supporting evidence so investigators can frame the right question without overstating causality.
Product Version Investigation
See which product version belongs in the investigation.
Compare released versions, effective dates, configuration context, changes, and field experience to keep the review anchored to the correct device revision.
Change Investigation
Trace product changes to the outcomes they may affect.
Relate design, component, supplier, software, and manufacturing changes to post-market signals and evidence while keeping relationships distinct from proof.
Supplier Investigation
Follow supplier context through to product impact.
Connect supplier, component, site, lot, change, and field records to support a complete review of potential product impact.
Component Investigation
Trace a component across the device lifecycle.
Bring specifications, suppliers, revisions, manufacturing context, affected products, and field evidence together for a focused component review.
Lot / Batch Investigation
Map lot context before assessing scope.
Connect manufacturing lots, sites, distribution paths, products, complaints, and evidence to make potential impact and remaining gaps visible.
Risk & Failure Investigation
Keep risk review connected to evidence and controls.
Relate hazards, risk controls, residual-risk observations, product context, and investigation evidence while preserving human review and approval boundaries.
Cross-System Investigation
Bring the investigation together across systems of record.
Use governed mappings to connect QMS, PLM, ERP, supplier, and manufacturing context while each source remains authoritative and provenance stays visible.
End-to-end solution story
Every solution follows the same governed path.
01Frame the question
Define the signal, scope, time window, and accountable review team.