Regulatory Submission Support
Technical documentation for TGA, FDA and EU submissions.
We prepare and organise the engineering content of regulatory submissions, from device descriptions and design specifications to risk and V&V summaries, working with your regulatory affairs specialists.
What’s included
What you receive
Benefits
Complete files
Nothing missing when reviewed.
Less rework
Fewer regulator questions.
Faster approval
Clear, well-organised evidence.
Where this fits in the process
- 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
Design controls set-up in 2–4 weeks; development and industrialisation over 6–24 months.
On-site and remote, with cleanroom partners in Australia and Asia. Every engagement starts with a free consultation and a fixed-scope proposal.
More Regulated Product Development & MedTech services.
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.
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Verification & Validation
Prove the device meets its requirements and user needs.
Learn moreLet’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