Alere Reader

Project Info

Case Study

Alere (now Abbott)
The project began as Alere Inc Reader, an innovative Lateral Flow device reader, designed for Point of
Care market. The project ran from start to finish (or from inception to production) and was completed in
record time – 9 months for the first variant of the device and additional 14 months for the advanced
connected system.
The following goals were achieved during the project:
– Complete IEC62304- compliant SDLC creation
– SDLC integration with ISO13485-certified QMS
– Development of a complete set of documentation needed for FDA software certification to Class
– Creation of basic (first-gen) and advanced (second-gen) of the device architecture
– Design and development of Embedded software
– ISO14971-compliant software risk management
– Assistance in IEC 60601 certification (EMC/EMI)
– Creation of Production EOL software
– Integration of Production EOL Test software with manufacturing facility
Once Abbott Laboratories acquired Alere Inc, the product was renamed to Abbott Digival and is available
for purchase on a variety of markets worldwide.

Project Photo