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TRONIOUS
Manufacturing

From released design to thousands of units a month

A controlled design transfer, then volume production where every unit is tested, traceable and released against a device history record.

Illustrative precision assembly and validation of an electronic therapy controller
Controlled productionAssembly, inspection and functional validation at every release gate
Stage 1

Design transfer

Design transfer turns a verified design into a process that produces the same device every time. Rushing it is the most common cause of production problems and recalls, so we treat it as its own phase with its own gate.

Transfer output

Device master record, supplier approvals, first article reports, process FMEA, validation protocols and reports, validated test methods, training records and pilot build data.

Active transfer gate

Production readiness review

Engineering, quality and production confirm the design is complete, verified and manufacturable. Open design issues are closed or formally accepted.

Stage 2

Volume production flow

Explore the route every unit takes through our facility, from incoming inspection to shipment.

Controlled production route10 recorded stations

From received components to quality-released shipment.

01–02 Materials03–05 Build06–07 Verify08–10 Release
Active station · Materials

Incoming inspection

Parts checked against specification, by sampling plan or 100% for critical parts

Control focusSpecification check and sampling plan
Quality controls

Built-in quality, every unit

Each control creates an inspectable record, so production history stays connected from component receipt through field support.

Controlled

Full traceability

Every unit is serialised and linked to its component lots, test results and operators, so any issue can be traced in minutes.

Controlled

Device history records

Electronic records for every unit and lot, available to you on request.

Controlled

Process monitoring

Statistical process control on key parameters, with yield and defect data reported to you on an agreed schedule.

Controlled

Nonconformance & CAPA

Defects are contained, investigated for root cause and corrected through our CAPA system.

Controlled

Change control

No change to parts, suppliers or processes without impact assessment and your written approval.

Controlled

Complaint support

We investigate returned units and supply the data you need for complaint handling and regulatory reporting.

Scaling

Grow without changing manufacturer

The production setup evolves with demand while the controlled record, test strategy and quality oversight stay connected.

  1. 01
    Stage 01Prove

    Pilot

    Volume profilePilot lots
    Production setup
    • Flexible cell
    • Engineers on the line
    • Rapid fixes
  2. 02
    Stage 02Stabilise

    Launch

    Volume profileCommercial launch
    Production setup
    • Dedicated workstations
    • Validated testers
  3. 03
    Stage 03Scale

    Volume

    Volume profileSustained demand
    Production setup
    • Dedicated line
    • Automated test
    • Safety-stock agreements
Connected at every stage
  • Controlled records
  • Validated test strategy
  • Quality oversight
Manufacturing transfer

Already in production elsewhere?We also take over manufacturing of cleared devices from other manufacturers.

Talk to us about a transfer