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MDARIXProduct intelligence
Platform · Product 360

Know the product, the version and the lot behind every complaint.

The device as it exists across versions, components, suppliers, lots and time, so an investigation starts from the right product record.

  • Available today2 capabilities
  • In a pilot2 capabilities
Product 360In a pilot

See the whole device in one place.

A decision-ready view of a medical device as it exists across product versions, intended configuration, components, suppliers, manufacturing lots, complaints, investigations, risks, and evidence.

The Product 360 screen is not in the free trial: there, products, versions and lots are read through Readiness, Complaints and Signals. The screen itself is opened in a pilot.

  • Configuration at a glance. See the released device configuration, active components, revision identifiers, suppliers, sites, and status in one controlled product context.
  • Version-aware impact. Compare product versions and follow a complaint or change to the affected configuration without losing source provenance.
  • Manufacturing context. Relate components, supplier records, sites, lots, and release history to the product configuration under review.
  • Post-market connection. Bring complaints, service observations, investigations, risks, and evidence into the same product story.
  • Safe decision support. Show missing links, contradictions, temporal limits, and unsupported conclusions instead of hiding uncertainty.
  • Searchable product record. Find a device, revision, component, supplier, lot, or linked signal quickly, then narrow the view by status, date, and authorized scope.
  • Data quality you can inspect. Surface missing attributes, conflicting source values, stale relationships, and unresolved mapping issues before they affect a review.
  • Connected system handoff. Bring context from PLM, QMS, ERP/MES, and supplier systems through versioned mappings: CSV exports today, live connections in a pilot. Each system keeps ownership of its data.
  1. Product
  2. Versions
  3. Configuration
  4. Components
  5. Suppliers
  6. Lots
  7. Signals
  8. Evidence
  9. Decision
Product Reality GraphIn a pilot

Map how everything about the product connects.

Map how a device, its versions, components, suppliers, sites, lots, changes, complaints, and evidence relate—so investigators can inspect the product story without mistaking a relationship for proof.

The connected graph is part of the Product 360 screen, opened in a pilot. In the free trial each complaint and case is linked to its product version and lot.

  • One connected product story. Start with a product or signal and traverse the authorized links that explain its configuration, manufacturing context, and field experience.
  • Relationship-first investigation. Use the graph to locate relevant components, suppliers, lots, changes, complaints, and observations across the device lifecycle.
  • Context before causality. A graph path organizes evidence context; it does not automatically establish a root cause or regulatory conclusion.
  • Visible gaps and conflicts. Highlight missing links, inconsistent source values, temporal limits, and contradictory evidence before review.
  • Ready for governed action. Carry provenance, scope, uncertainty, and human accountability from exploration into the decision package.
  1. Product
  2. Version
  3. Component
  4. Supplier
  5. Lot
  6. Signal
  7. Evidence
  8. Review
Product Version IntelligenceAvailable today

Know exactly which revision you are investigating.

Keep every medical-device revision anchored to its product identity, approved configuration, effective dates, verification context, and field experience—so reviewers can see exactly which version was relevant to an investigation.

Complaints, signals and trend checks are counted per product version, and every screen of a case works on the version you choose.

  • A controlled revision record. Keep product identity separate from product version identity, status, effective dates, and release ownership.
  • Change-to-evidence trace. Relate software or configuration changes to requirements, verification observations, complaints, affected lots, and review evidence.
  • Release readiness context. Make approval state, superseded versions, known limitations, and required human review visible before a release is relied upon.
  • Temporal clarity. Separate current, event-as-of, and known-as-of views so historical context is not rewritten by later updates.
  • Impact without overclaiming. Identify potentially affected products, components, sites, and signals while keeping causal conclusions bounded by evidence.
  1. Product
  2. Revision
  3. Change
  4. Verify
  5. Release
  6. Monitor
  7. Impact
  8. Review
Timeline IntelligenceAvailable today

Separate what happened from what was known, and when.

Reconstruct the sequence around a product signal and distinguish when a change became effective, when it was recorded, and when the organization could have known about it.

A case can be read as it is now, as it happened, or as it was known on a date you choose.

  • See the sequence. Place product, version, configuration, supplier, lot, complaint, and evidence events on one readable investigation timeline.
  • Three views of time. Switch between current, event-as-of, and known-as-of context without mixing their meaning or rewriting history.
  • Explain the change window. Identify what changed before or after a signal, which records support the timing, and where the chronology is incomplete.
  • Review with provenance. Keep each event tied to its source, organization, product version and limitations before it informs a human decision.
  1. Effective
  2. Recorded
  3. Known
  4. Change
  5. Signal
  6. Evidence
  7. Review
Availability

Every capability says where it stands.

The labels are the roadmap's: nothing is marked Available today until it works in a free trial workspace.

Available today

In every workspace, including the 30-day free trial.

In a pilot

Built and validated together during a pilot.

Planned

Not available yet.

See the roadmap
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.

Start free trial