For healthcare teams who need to ship

We help healthcare teams build with clarity

We help healthcare teams build with clarity, rigor, and compliance.

Product management and engineering under one roof, so the right thing gets built and holds up under scrutiny.

What we do

Product Design & Management

We scope, prioritise, and own the roadmap with you, so the build stays aimed at what actually needs to exist.

Software Development

Production-grade software, shipped in structured phases with architecture, testing, and full visibility.

AI Automation for Healthcare Workflows

AI built into the operational day-to-day, so the admin stops pulling your team away from care.

Submission-Grade Documentation

QMS, risk files, and SaMD documentation written to withstand regulatory review, whether we built the product or you did.

“Blue Arrow did what they said they would, when they said they would. When something went sideways, they owned it instead of explaining it away, and the work held up. I never felt like I was chasing them. That’s rarer than it should be.”
Stephen Pech

Stephen Pech, CEO & Co-Founder / Radiology startup

Three ways to work with us

Whether you’re validating an idea, building it, or fixing what you inherited, there’s a small first step that earns the next.

Product Development

For teams building or fixing a healthcare product.

10 business days·A$4,500 fixed

Build Readiness Review

Clarity before code. Ten days to know what to build, what it will cost, and what stands between you and regulatory review.

Best for

Starting a build · Mid-build and unsure · Regulation in play

See the 10-day plan →
4–12 weeks·Milestone-based

Build Sprint

Production-ready software, shipped in structured phases with full visibility.

Best for

Funded teams · MVP to v1 · Regulated feature builds

2–6 weeks·Scoped

Rescue & Hardening

Stabilise, document, and bring your product to scrutiny-ready.

Best for

Compliance gaps · Post-handoff cleanup · Regulatory readiness

Not developers for hire. A team that owns delivery.

What a dev shop gives you

“We’ll build what’s in the ticket”

What you actually need

The right thing, scoped before code

What Blue Arrow does

Product management owns the scope first

What a dev shop gives you

“Here’s your code, good luck”

What you actually need

A product that survives an audit

What Blue Arrow does

Submission-grade documentation, built alongside

What a dev shop gives you

“That’s out of scope”

What you actually need

Someone who flags the regulatory risk

What Blue Arrow does

TGA and Privacy Act awareness from day one

What a dev shop gives you

“We can add AI”

What you actually need

Automation that fits the clinical workflow

What Blue Arrow does

AI built into the systems your team already uses

Compliance isn’t bolted on at the end. It’s how we build from the first line.

Built to the standard Australian healthcare expects.

Privacy Act and APPs aligned: patient data handled to the Australian Privacy Principles.

Regulatory-ready by design: TGA and IEC 62304 / SaMD considerations built in, not bolted on.

We never hand your patient data to anyone else’s model. Full stop.

Documented and auditable: every build ships with the evidence trail a regulator expects.

Why Blue Arrow?

Principal-led, not delegated

Every engagement is led by a principal who owns the outcome. You always know who’s accountable.

Product management rigor, not ticket-taking

We scope the right thing, challenge the roadmap, flag risk early, and make sure what ships is what needs to exist.

Regulation-aware from day one

QMS documentation, risk-based testing, and SaMD awareness baked into how we build.

What this looks like in practice

Medical imaging workstation with diagnostic scans
FEATURED · MEDICAL IMAGING · SaMD

DICOM Middleware Build

Designed and built DICOM middleware that moves imaging data reliably between the PACS and the AI model, so studies flow automatically instead of being shuttled by hand.

Architecture to production, live integrations running, and built regulation-aware from day one

Regulatory documentation and compliance paperwork on a desk
FEATURED · REGULATORY DOCUMENTATION · SaMD

IEC 62304 Documentation

Produced submission-grade IEC 62304 software lifecycle documentation: development plan, software requirements and architecture, risk management, and verification, all traceable end to end.

A submission-ready documentation package the team can take straight to regulatory review

Continuous glucose monitor on arm with smartphone app
DIABETES MANAGEMENT · DIGITAL HEALTH

Chronic Disease Management Platform

Full product build with mobile apps, CGM integration, gamification, and clinician-facing EMR portal.

From concept to live platform serving active patients

Doctor reviewing patient data on tablet
REMOTE PATIENT MONITORING · US HEALTHCARE

RPM Platform for Clinical Practice

Complete mobile build with wearable integration and real-time vitals tracking.

0+

patients actively using the platform

Elderly person receiving compassionate care from staff
AGED CARE · GOVERNMENT

Aged Care System Modernisation

System selection, integration design, and modernisation roadmap for a federal agency.

National infrastructure modernisation roadmap delivered

Common questions

Ready to talk?

No pitch, no pressure. Just a focused conversation about what you’re building.

Prefer to write first? hello@bluearrowconsulting.com.au