Regulated Product Development & MedTech
Regulated products, designed and manufactured right from the start.
Medical devices and other regulated products demand more than good engineering: design controls, risk management, verification and validation, and a documented manufacturing process. We develop and industrialise regulated products for MedTech and other tech-forward industries, including connected devices, robotics, clean energy and defence.
Our team brings ISO 13485 design and manufacturing experience, cleanroom moulding and assembly know-how, and practical support for preparing the technical documentation needed for TGA, FDA and EU submissions.
- MedTech start-ups and scale-ups developing Class I–III devices
- Companies in tech-forward industries with regulatory or safety requirements
- Manufacturers transferring regulated products to new suppliers or sites
Regulated product development (design controls).
Every engagement follows a clear, staged process with defined decision gates, so you always know where your project stands and what happens next.
- 01User needsIntended use and users
- 02Design inputsRequirements and risks
- 03Design outputsDesign and specifications
- 04◆ ReviewVerificationOutputs meet inputs
- 05◆ ReviewValidationMeets user needs
- 06TransferValidated manufacturing
- 07◆ GateSubmissionTGA, FDA, EU technical file
Regulated Product Development & MedTech services.
Select a service to see what is included, what you receive and the benefits.
Design Controls & ISO 13485 Development
Development that builds your design history file as you go.
Learn more
Risk Management (ISO 14971)
Hazards identified and controlled through the lifecycle.
Learn more
Verification & Validation
Prove the device meets its requirements and user needs.
Learn more
Regulatory Submission Support
Technical documentation for TGA, FDA and EU submissions.
Learn moreMedTech Manufacturing & Cleanroom Production
Validated manufacturing for medical devices.
Learn more
Tech-Forward Industries
Connected devices, robotics, clean energy and defence.
Learn moreWhat changes for your business.
Faster approvals
Design history and technical files built as you go.
Lower regulatory risk
Risk management and validation done properly.
Scalable manufacturing
Validated processes ready for volume, onshore or in Asia.
Regulated Product Development & MedTech: common questions.
Do you prepare regulatory submissions?
We prepare and organise the engineering and technical documentation for TGA, FDA and EU submissions, such as design history, risk files, verification and validation reports, and work alongside your regulatory affairs specialists.
Which industries count as tech-forward?
MedTech and diagnostics, connected and IoT devices, robotics and automation, clean energy and battery products, and defence and aerospace components.
Design controls set-up in 2–4 weeks; development and industrialisation over 6–24 months.
Every engagement starts with a free consultation and a fixed-scope proposal with clear deliverables, timing and success measures.
Articles on Plastic Part Design.
Designing in alternate resins to reduce supply risk
Products designed around a single resin grade are exposed to price spikes, shortages and discontinuation. How to design and qualify alternate materials in advance, so you can switch quickly when supply is disrupted.
Designing plastic parts for recyclability
Recyclability is decided at the design stage: material choices, joining methods, labelling and colour all determine whether a part can be recovered. Practical design rules for plastic parts that can be recycled at end of life.
Case studyCase study: designing an electronics enclosure for recyclability
A European customer required a consumer electronics brand to show how its products could be recycled. Cutting material types from seven to three, replacing screws with snap fits and moulding in labels raised recyclable mass from 61% to 94% and cut disassembly time from 140 to 55 seconds.
More from Start-ups, MedTech & Funding.
Let’s turn your next idea into a market-ready product.
Whether it’s a bold new product, a strategy that needs sharpening or an operation that should be doing more, a conversation with a senior consultant is the fastest way to find out what’s possible.
- Free initial consultation with a senior engineer
- Response within one business day
- Confidentiality and NDA available on request
Prefer to give us the full picture? Use the detailed project enquiry form