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MDARIXProduct intelligence
Solutions

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.

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.

02Connect the context

Bring product, version, change, supplier, lot, complaint, and evidence context together.

03Inspect the uncertainty

Separate what is observed from what is inferred, contradicted, missing, or still unknown.

04Move to governed action

Preserve provenance and limitations while authorized humans review and decide.

Design partners

Bring one real investigation. See the whole story in one place.

Start with exports from your quality, product and supplier systems. Your systems of record stay where they are.