Cerium's new Colorimeter - Curve

Cerium
 

i2r Medical has recently completed a 12-month project to design and develop Cerium’s new version of its Colorimeter. This is an optical assessment device that determines the colour of precision tinted lenses which are used to reduce visual stress, dyslexia and other medical conditions relating to a patient’s sight. Following the success of its predecessor, Cerium wanted a new system that utilised digital colour management by way of software-controlled LED’s that could provide greater precision in the colour selection, hue and brightness.

i2r Medical was called upon to take responsibility for the Design, Prototyping, Regulatory Affairs and transfer to manufacture to achieve CE marking and production. Responsibilities included the management of Electronic and Software design, organisation of manufacturing and complete transfer to production.

The appeal of i2r Medical to Cerium was our ability and experience in managing all the elements of medical device design and development. Our approach reduces lead times and allows for a more cohesive development pathway.

See more of the Curve at Cerium’s website: https://ceriumvistech.com/

i2r Medical undertook all the following to achieve the project goals of bringing the device to market:

  1. 1. Design and Development
    • Conceptual design
    • 3D CAD generation
    • Prototyping using ABS machining, 3D Printing and Silicon moulding
    • Detailed design and engineering of plastics and metalwork
    • Management of electronics manufacturing and validation testing
  2. 2. Regulatory Compliance
    • Compilation of a full Technical File to meet CE marking regulations
    • Verification and Validation test programme
    • Guidance to suppliers to ensure they meet the required Regulatory standards
    • Compliance with FDA requirements
  3. 3. Transfer to manufacture
    • Selection of sub-contractors for the manufacture of the RIM mouldings, metal fabrication, ABS machining, electronics and paint finishing.
    • Full manufacturing documentation to enable assembly, manufacturing and testing of completed device.