Have a product idea? Find out what it really takes.
Rajan Solutions is an independent Australian engineering and regulatory advisory consultancy helping founders and startups determine whether physical, hardware and connected products can be developed, manufactured and taken to market before significant money is committed. We also support medical-device teams with classification, quality systems, design controls, audits and regulatory pathways across Australia, the United States and Europe.
Two ways in — one for any hardware idea, one for medical devices.
Clearly scoped advisory engagements for physical-product feasibility and medical-device regulatory planning. The feasibility study is offered at a transparent fixed price, while medical-device work is scoped according to the product, markets and support required.
Hardware & product feasibility assessment
Fixed priceBring us your physical-product idea—mechatronics, embedded electronics, IoT or connected hardware. We assess potential architecture, development pathway, manufacturing approach, standards, major risks and indicative costs before you commit to prototypes, suppliers or major development expenditure.
Discuss your product idea →Classification & market entry strategy
Fixed priceWhich class, which markets, and in what order — a clear-eyed strategy across TGA, FDA and EU MDR before you commit the roadmap.
ISO 13485-aligned design & development model
HourlyWe set up the design and development discipline your device — and your future auditors — expect, sized to your stage. For the full system, we work alongside your ISO 13485-certified manufacturing partners.
Scheduled check-ins
HourlyA quality and regulatory sounding board on a regular cadence — design reviews, decisions and course corrections before small gaps become expensive ones.
Internal audits
Fixed priceIndependent internal audits of your quality system, delivered by a certified ISO 13485 internal auditor — findings you can act on, not a paperwork exercise.
TGA submission (lodged as your registered agent)
HourlyAs a registered Australian TGA submission agent, we prepare and lodge your TGA application directly — one less handoff, one fewer place for things to go wrong at the finish line.
Products we've helped move forward.
Two portfolios, one engineering backbone — pick the one that looks like your idea.
Smartphone time-off ecosystem
Hardware + app ecosystem for planned phone downtime.
UV water treatment mesh solution
UV-based water treatment with mesh-connected units.
Fleet telematics
Vehicle telematics platform for fleet operators.
IoT multi-function cooker
Connected multi-function kitchen appliance.
AirPrint server
Embedded AirPrint print server for small office and home networks.
GateGuard
Detection and alert system for approaching gate activity.
Wearable ECG monitor
Wearable electrocardiogram monitoring device.
Syringe infusion pump
Syringe-driver infusion delivery system.
Volumetric infusion pump
Large-volume infusion delivery system.
Skin treatment equipment
Energy-based aesthetic / dermatological device.
Baby HR & SpO₂ monitor
Infant heart-rate and pulse-oximetry monitor.
Prostate ablation device
Minimally invasive prostate ablation system.
Telehealth data acquisition system
Connected telehealth physiological data acquisition system.
Hormone tracking system
Connected hormone-tracking platform (software as a medical device).
We now have a much clearer understanding of what it will take to bring the product to market and can decide how to move forward with confidence.
— GateGuard founder, Perth WA
Classification-aware support across device, software and evidence planning.
Support is tailored around intended use, claims, software role, use environment, risk profile and target markets — helping teams define the right process and evidence expectations early. Quality-system work is led by a certified ISO 13485 internal auditor. Focus is on Class I, IIa and IIb devices, not Class III.
Australia (TGA)
European Union (EU MDR)
United States (FDA)
Software (IEC 62304)
Set up the process, help the team use it, then step back until needed.
Rajan Solutions is designed for startup teams that need targeted process and project support, not permanent dependency.
Assess
Understand the product, intended use, current evidence, target markets and immediate gaps.
Define
Set up the right processes, templates, ownership and review points for the stage of the company.
Embed
Help the team apply the process during real development work, reviews, changes and V&V planning.
Return
Step back and come in for audits, design reviews, readiness checks or targeted support as needed.
Scope of support. Rajan Solutions provides process definition, project support, readiness review, gap assessment, planning, templates and advisory support. As a registered Australian TGA submission agent, it can lodge TGA submissions on behalf of manufacturers. It does not certify or approve devices, does not submit to the FDA or a Notified Body, does not guarantee regulatory clearance or approval, and does not replace a manufacturer's own regulatory responsibilities.
Start with a conversation about your product.
Tell us briefly what you are developing, what stage it is at and where you need clarity. This can be a hardware, IoT, connected-product or medical-device idea.
Book a no-charge, no-commitment introductory discussion to talk through your product, current stage and whether Rajan Solutions can help. No preparation is required. Let us know if an NDA is needed for this call.
Book a no-charge intro callFrequently asked questions.
Can you assess a product at the idea stage?
Yes — and it's strongly recommended before you commit significant money or time. Early assessment identifies major technical, manufacturing, regulatory and commercial unknowns while they're still cheap and easy to address.
What does the feasibility study assess?
The assessment considers potential technical architecture, development pathway, manufacturing approach, applicable standards, major risks, key uncertainties and indicative development, testing and production costs
How much does the hardware feasibility study cost?
The fixed-price hardware and product feasibility study is A$5,000 + GST. Payment is 50% at commencement and 50% on delivery. The study generally takes approximately two weeks, depending on the complexity of the product and the information available. Medical device classification assessment on the Rajan Solutions letterhead is an additional A$1,500 + GST under the same payment terms.
Can you support TGA submissions?
Yes. Rajan Solutions supports medical device classification, regulatory strategy, submission preparation and — as a registered Australian TGA submission agent — the TGA submission itself.
Do you provide product design services?
Rajan Solutions provides independent feasibility, regulatory and development-pathway advice rather than in-house design or manufacturing. Where you need execution partners, we present local and international vendor options and compare their relative benefits, so you choose with full visibility.
Can you work with our existing engineering team?
Yes. We support your team from a process and regulatory angle throughout every phase of design — effectively acting as your ISO 13485 regulatory support — without replacing your engineering work.
Do you work with clients outside Australia?
Yes. Rajan Solutions supports Australian and international clients, including products intended for Australia, the United States and Europe.