Our Services

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Concept Generation

  • Idea generation and design visualisation
  • User need definition, ergonomic assessment and translation to design inputs
  • Requirements capture 
  • Concept evaluation and selection
  • Initial prototyping and evaluation

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Design & Development

  • Requirements management and transformation to design criteria and specifications
  • CAD detail design (SolidWorks) 
  • Proof of concept prototypes for functional and technical feasibility
  • Design for manufacture and assembly
  • DFMEA and design robustness  

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Product Verification & Testing

  • Exploratory test and hand assembly fixtures
  • Product functional and performance analysis
  • Product characterisation and benchmarking
  • Microscopic imaging, metrology and design analysis
  • Design verification testing  

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Design Control Process

  • Design control process understanding and adherence
  • Design management and change control implementation
  • Risk management
  • Regulatory and quality requirements understanding and compliance with class 2 and 3 medical device development
  • Specification and requirements management  

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Industrialisation & Commercialisation

  • Design management up to clinical trial and beyond to device scale-up and commercialisation
  • Design transfer
  • Manufacturing & assembly process troubleshooting and analysis
  • Component robustness and repeatability
  • Tooling scale-up process validation support  

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Additional Services

  • Graphics and branding
  • Packaging design
  • Instructions for use design and development
  • Industrial design and mechanical design
  • Supplier management and engagement