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MDARIXProduct intelligence
Post-market surveillance and complaint handling for medical devices

See the risk in your post-market data, not just collect it.

Complaints, reporting clocks, trend signals, investigations and CAPA in one traceable place, linked to the product version, lot and supplier behind each complaint. Try it on your own data today, no demo call needed.

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  • Works above QMS, PLM, ERP and supplier systems
  • Every finding links to its records
  • Authorized humans decide and sign
Inspection readiness

See your quality loop the way an inspector will.

Eight checks shaped by what FDA inspections cite and by the EU, UK and Canadian vigilance rules, read from your own records every day. Each one opens the records behind it, and the weakest link is named.

Illustrative · synthetic data

2 of 8 inspection checks clear

Hidden complaints, a harm complaint closed without an investigation, a CAPA without an effectiveness check, and field data that never reached the risk file: what an inspector would find first. Your free trial starts with sample data that tells this story.

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1. Hidden complaints found Cancelled, inquiry or No Fault Found records that carry signs of a complaint

One investigation, start to finish

Why did pressure-alarm complaints rise after OrbitCare 300 Rev B?

From a rising signal to the lot, the component and the supplier, reviewed by every function in one place and decided by a person.

Signal

Pressure-alarm complaints per week

Weekly complaints: 6 in the 13 weeks before Rev B is released in week 13, 36 in the 13 weeks after (from about 2 a month to about 12)024Rev B released · CHG-014Week 1: 1 complaintsWeek 2: 0 complaintsWeek 3: 1 complaintsWeek 4: 0 complaintsWeek 5: 0 complaintsWeek 6: 1 complaintsWeek 7: 0 complaintsWeek 8: 1 complaintsWeek 9: 0 complaintsWeek 10: 0 complaintsWeek 11: 1 complaintsWeek 12: 0 complaintsWeek 13: 1 complaintsWeek 14: 1 complaintsWeek 15: 2 complaintsWeek 16: 2 complaintsWeek 17: 3 complaintsWeek 18: 2 complaintsWeek 19: 3 complaintsWeek 20: 3 complaintsWeek 21: 3 complaintsWeek 22: 3 complaintsWeek 23: 4 complaintsWeek 24: 3 complaintsWeek 25: 3 complaintsWeek 26: 4 complaintsWeek 1Week 13Week 26
Where it concentrates

Complaints per lot

Complaints per lot: the two lots built with the new supplier's sensors hold 30 of 42 complaints; 2 complaints name no lotLot 001 · Rev ALot 001 (Rev A): 2 complaints2Lot 002 · Rev ALot 002 (Rev A): 3 complaints3Lot 003 · Rev BLot 003 (Rev B): 17 complaints, new supplier's sensors17Lot 004 · Rev BLot 004 (Rev B): 13 complaints, new supplier's sensors13Lot 005 · Rev BLot 005 (Rev B): 3 complaints3Lot 006 · Rev BLot 006 (Rev B): 2 complaints2

Built with the new supplier's sensors. 2 of the 42 complaints name no lot.

  1. A signal rises

    Pressure-alarm complaints rise from about 2 to 12 a month after Rev B is released. A change is a lead, not a cause.

  2. Scope to the lot and the supplier

    Lots 003 and 004, built with the new supplier's pressure sensors, hold 30 of the 42 complaints.

  3. Weigh the explanations together

    Quality, regulatory, product, supplier quality and manufacturing review the same evidence, competing hypotheses and open questions.

  4. Decide and sign

    An authorized person decides and signs, and the audit trail keeps every step. AI is off in the free trial: every step works by hand.

Illustrative example with synthetic data. No customer data is shown.

Typical source systems

Your systems stay the record. MDARIX connects the story.

Each system keeps its data. Today MDARIX imports CSV exports from them; live connections are built in a pilot. Every record is checked and linked to versions, lots, components, suppliers, risks and evidence.

Eight customer systems flow into MDARIX, which serves product records, investigations, Ask MDARIX and decisionsQMSComplaints · CAPAsDocument controlQuality events · documentsPLMItems · BOM · changesERPBatches · plants · vendorsMESProduction · genealogyLIMSTest resultsRisk fileRisks · FMEA · controlsSupplier portalSuppliers · certificatesProduct recordsVersions, lots, components, suppliersInvestigationsQuestion, evidence, hypothesesAsk MDARIXAnswers with their evidenceDecisionsSigned, traceable, auditedMDARIXchecked importyour data only
  • QMS Complaints · CAPAs
  • Document control Quality events · documents
  • PLM Items · BOM · changes
  • ERP Batches · plants · vendors
  • MES Production · genealogy
  • LIMS Test results
  • Risk file Risks · FMEA · controls
  • Supplier portal Suppliers · certificates
Trust by design

Built for regulated teams.

Isolated data per customer

The database itself enforces each organization's boundary.

AI off in the trial

Every step works by hand. AI stays advisory and cites its evidence.

Signed decisions

Approval authority by role, re-authentication and no self-approval.

Complete audit trail

Who did what, when and why, ready to export.

Covers FDA, EU MDR, UK and Canada reporting How MDARIX earns trust
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.

In your free trial
  • 30 days, free, with no credit card
  • Up to 3 users and 5,000 uploaded rows
  • Sample data that tells the quality story in nine chapters
  • Your own CSV exports, checked for problems and personal data before import
  • Fourteen step-by-step videos
  • AI is off during the trial: every step works by hand
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