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A diagnostic product development programme is available to provide both consultancy and practical support to companies. Projects of mutually agreed specification are undertaken from proof of concept to a CE marked diagnostic test.
The service draws on our experience of the technology to accelerate partner companies product launch to ensure early access to new markets.
Design and plan
Prototype testing
Assay optimisations
Assay validation (3 batch analysis)
- Technical
- Reproducibility
- Accuracy
- Robustness
- Tolerance
Assay Verification
- In-house comparison to gold standard method using clinical samples
- Reproducibility
- Beta site testing
Regulatory
- Preparation of Instructions for Use
- Risk Analysis
- Technical File
- Registration within different countries
Launch
If you would like further information or want to discuss a product development proposal please call DxS on +44 161 606 7201 or email info@dxsdiagnostics.com. |
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