More Case Studies

CERUS

INTERCEPT

The Intercept Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid-targeting mechanism of action of the Intercept treatment is designed to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, as well as emerging transfusion threats such as chikungunya, malaria and dengue.

WE DELIVERED

  • Architecture design, requirements capture

  • Systems engineering

  • DHF documentation

  • Risk management file

  • Agency testing requirements, analysis and pre-testing

  • Mechanical engineering

  • Electrical engineering

  • Software engineering (62304 life-cycle)

  • ROHS system engineering

  • Reliability engineering

  • Advanced detection algorithms for multiple conditions/events

  • Prototyping, rapid turn PCB

  • Preliminary agency testing

  • System electrical, software and mechanical integration and testing

  • Formal verification testing

  • Agency testing, UL, FCC, EU

  • Transfer to manufacturing

 

 
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