Indianapolis-based medical device quality management software (MDQMS) platform Greenlight Guru announces its selection as the premier quality management system (QMS) for the National Institute of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program, led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB). This program aims to improve the speed of innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. 

As the only QMS provider currently available to all projects in the RADx program, Greenlight Guru facilitates rapid QMS implementation, development, and commercialization for point-of-care diagnostics targeted to support at-home COVID-19 testing. 

“Continuing to improve and ramp up testing is a critical component to battling the COVID-19 pandemic,” says David DeRam, CEO at Greenlight Guru. “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.” 

The rapid and continued global spread of COVID-19 has created a dire need for accurate, reliable, and accessible testing on a massive scale. Through the RADx program, funded projects—including new applications of existing technologies—aim to make tests easier to use, more accessible, and more accurate. 

The NIH has moved several advanced diagnostic technologies swiftly through the development pipeline toward commercialization and broad availability, making millions of tests per week available to Americans, particularly those most vulnerable to and/or disproportionately impacted by COVID-19. In preparation for the 2021-2022 fall flu season, even more diagnostic systems are planned for commercialization.

“Returning safely to normalcy depends on our ability to streamline and speed up the COVID-19 testing process,” says Michael B. Wolfson, NIBIB program director and program manager for RADx Tech. “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 NIBIB, NIH, and the Department of Health and Human Services.