NIH has chosen Greenlight Guru to provide quality management software for its COVID-19 rapid diagnostics program.
The agency launched the Rapid Acceleration of Diagnostics (RADx) program in March 2020 to speed the development, commercialization and implementation COVID-19 testing technologies. As the only QMS provider currently available to all projects in the RADx program, Greenlight Guru enables rapid QMS implementation, development and commercialization for point-of-care diagnostics targeted to support at-home COVID-19 testing, according to the Indianapolis-based company.
“Continuing to improve and ramp up testing is a critical component to battling the COVID-19 pandemic,” said Greenlight Guru CEO David DeRam in a news release. “It is our responsibility as medical device industry experts to play our part in advancing these tests, which is why we are partnering with the NIH. Our ability to support RADx projects through our focus on medical device quality management for purpose-built solutions and rapid implementation of pre-validated systems is unparalleled in comparison to what other industry players can offer.”
In addition to moving several advanced COVID-19 diagnostic technologies through development, RADx is preparing for the 2021-2022 fall flu season.
“Returning safely to normalcy depends on our ability to streamline and speed up the COVID-19 testing process,” said Michael B. Wolfson, RADxTech program manager. “The use of Greenlight Guru’s MDQMS platform allows our participants to focus on innovation instead of constantly worrying about compliance, efficiency and other concerns often associated with legacy quality management processes.”
This project has been funded in whole or in part through a $1 billion investment via federal funds from the National Institute of Biomedical Imaging and Bioengineering, NIH and the Department of Health and Human Services. Greenlight Guru is a subcontractor of VentureWell for this project.
