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TRONIOUS
Development process

Phase-gated, with a deliverable at every gate

Six phases, each closed by a gate review that you approve. Nothing moves forward on assumptions, and every phase produces documentation that goes straight into your design history file.

  1. 01Concept & feasibilityFeasibility report, regulatory strategy, project plan and quote
  2. 02Design inputs & planningDesign and development plan, requirements specifications, risk management plan
  3. 03Detailed designFrozen design, drawings, BOM, firmware release candidate, design review records
  4. 04Verification & validationTest reports, traceability matrix, risk management report, usability engineering file
  5. 05Regulatory submissionSubmission-ready documentation, labeling set
  6. 06Design transfer & productionValidated processes, first production lot

Phase 1 of 6: Concept & feasibility

  1. Concept & feasibility

    Typically 4–8 weeks

    We work out what the device must do, who uses it, and whether it can be built and cleared at your target cost.

    • User needs and intended use statement
    • Device classification and regulatory pathway for US, EU and Australia, including predicate search for a 510(k)
    • Competitor and patent landscape review
    • Proof-of-concept prototypes for the riskiest functions
    • Target cost, budget and timeline

    Gate 1 deliverables: feasibility report, regulatory strategy, project plan and quote

  2. Design inputs & planning

    Typically 3–6 weeks

    User needs become measurable engineering requirements, and the risk management file starts.

    • System, hardware, firmware and app requirements
    • Risk management plan and initial hazard analysis to ISO 14971
    • Applicable standards list and test plan outline
    • Usability plan and user profiles to IEC 62366-1

    Gate 2 deliverables: design and development plan, requirements specifications, risk management plan

  3. Detailed design

    Typically 3–9 months

    Mechanical, electronics, firmware and app engineering run in parallel, in short build-and-test iterations.

    • Two or three prototype rounds, from works-like to looks-like to production-intent
    • Design reviews at each iteration, with independent reviewers
    • EMC and electrical safety pre-compliance testing on prototypes
    • Formative usability studies with real clinicians or users
    • Design FMEA and updated risk analysis
    • Supplier selection and tooling for moulded parts

    Gate 3 deliverables: frozen design, drawings, BOM, firmware release candidate, design review records

  4. Verification & validation

    Typically 2–4 months

    We prove the design meets every requirement (verification) and meets users' needs (validation).

    • Third-party IEC 60601-1, 60601-1-2 and collateral standard testing at an accredited lab
    • Performance and endurance testing on our in-house rigs
    • Software verification and cybersecurity testing
    • Biocompatibility evaluation for patient-contact materials
    • Summative usability validation
    • Packaging and transit testing

    Gate 4 deliverables: test reports, traceability matrix, risk management report, usability engineering file

  5. Regulatory submission

    Review times set by each regulator

    We prepare the submission content. Your company, as legal manufacturer, submits to the FDA, your notified body and the TGA, and we support you through questions.

    • 510(k) content, with FDA eSTAR formatting
    • EU MDR technical documentation and GSPR checklist
    • Support for your Australian sponsor's ARTG application
    • Labeling, IFU and UDI data
    • Responses to regulator questions and deficiency letters

    Gate 5 deliverables: submission-ready documentation, labeling set

  6. Design transfer & production

    Typically 2–3 months

    The verified design becomes a validated production process, then scales to volume.

    • Device master record, supplier approvals and first article inspection
    • Process validation and test method validation
    • Pilot lots, then ramp to volume production

    Gate 6 deliverables: validated processes, first production lot. Full manufacturing details →

Our quality system follows ISO 13485:2016 and FDA's Quality Management System Regulation (QMSR, 21 CFR 820), which took effect in February 2026. Timelines are typical ranges and depend on device complexity and classification.