Design Controls & ISO 13485 Development
Development that builds your design history file as you go.
We set up and run design controls aligned with ISO 13485 and FDA 21 CFR 820, so every requirement, design decision, review and change is documented and traceable.
What’s included
What you receive
Benefits
Audit-ready
Documentation regulators expect.
Fewer surprises
Traceability catches gaps early.
Faster submissions
Evidence ready when you need it.
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.
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.
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Regulatory Submission Support
Technical documentation for TGA, FDA and EU submissions.
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