Clinical Evaluation

Testing new products and providing the necessary clinical evaluation to ensure timely cE marking
Internal Clinical Testing

Due to our vast range of CE Marked contact lens designs and materials, using our formal processes, we can self-certify CE Marking of products based on predicate devices and clinical evaluations.

This contributes to the fast and flexible approach we offer for rapid prototyping and concept proving.

Route to CE Marking

We follow the route to CE Marking using clinical evaluation for Class IIa medical devices and following the requirements stipulated in the
Medical Device Directives.

  • Risk assessments based on our extensive experience with designs and materials
  • Literature searches
  • Internal clinical trials conducted in accordance with MHRA regulations and ethical approval guidelines
  • External clinical trials commissioned from bodies such as Eurolens Research

For fast prototyping and concept proving

Equipment
  • Video slit lamp
  • Multiple topography machines
  • Eaglet Eye surface profiler
  • Contrast sensitivity testing
  • Finite Element Analysis modelling
  • Through university partners, access to:
    • OCT
    • Pentacam
    • Corvis STL
    • IOLMaster 500
    • Aberrometry
Experienced clinicians
  • GOC registered practitioners
  • Industry and research-based experience
  • Understanding of every type of contact lens modality
  • Extensive work in trialling new and innovative products and taking them to market
  • Ability to write journal and CET articles
  • Experience in developing training collateral