Ophthalmic products and devices include a wide range of items from glasses and contact lenses to intraocular lenses, implants, diagnostics, lasers, surgical instruments as well as opthalmically administrated drops, ointments and other medications.

How Smithers can help

Smithers supports developers of opthalmic products with:  
  • Materials: Expert support with selection, characterization and compatibility
  • Compliance: Testing to help you demonstrate regulatory with FDA, MHRA, EMA, USP and ISO as well as BPOG and PQRI guidelines.
  • Extractables and Leachables: extensive expertize in controlled extraction studies, identification of extractables and leachable profile assessments.
  • Device Testing: From testing container closure to connection compatibility, we test devices to ensure they perform as designed and meet relevant regulations.
  • Transit studies: Simulated distribution testing to recreate supply chain condition faced by your device.
  • Product simulation studies: Combination of testing studies to simuate real life usage of your device and the impact this might have on patient safety through its lifetime.

 

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