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ALLERGAN

TRUE TEAR FAMILY

Allergan has developed a medical device for the treatment of dry eye syndrome. The device implements communication to a mobile or other device using BTLE. TrueTear is the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients. TrueTear consists of a handheld neurostimulation device with a disposable tip that is inserted into the nasal cavity to induce the production of natural tears, providing a novel and innovative approach for patients with inadequate tear production to improve dry eye symptoms in adult patients with severe dry eye symptoms.

WE DELIVERED

  • IoT development

  • BLE to mobile app, mobile application BLE stack integration and development

  • Regulatory compliance

  • Coexistence requirements capture and traceability

  • DHF documentation

  • BTLE coexistence testing

  • Coexistence test reports

  • Systems engineering

  • DHF documentation package

  • Cyber security risk analysis

  • Agency testing requirements, analysis and pre-testing

  • Electrical engineering

  • Software engineering

  • PCBA layout

  • Prototyping, rapid turn PCB

  • Preliminary agency testing

  • Integration and testing

  • Agency testing, UL, FCC, EU

  • System and software test protocols

  • Software unit testing and unit integration testing

  • Compliance with EN62304 software life-cycle standards

  • System, hardware and software verification

  • EMC compliance and mitigation

  • 60601-1-2 and FCC, EU certification oversight

  • Verification

  • Transfer to manufacturing

 
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