Greenlight Guru (Indianapolis) recently announced that it’s added an AI and machine learning recommendation engine to its medical device quality management software platform.

The newly launched Halo for Change Management provides recommendations of items impacted by a change order and real-time visibility to discover, assess and manage the impact of a change, according to Greenlight Guru.

“Our recent 2021 State of Medical Device Quality Report revealed that, currently, 60% of organizations rely on traceability for conducting change, while 28% of medical device professionals say it still takes a full day or more to run a change impact analysis. This tells us that medical device professionals are working from a reactive state that is tedious and error-prone, limiting organizations from gathering the quality insights that are needed to stay ahead of change,” Greenlight Guru CEO David DeRam said in a Jan. 18 news release.

“Halo for Change Management is the first AI feature that allows you to predict the impact of your change and provides you with recommendations for what is impacted by a change, giving you real-time visibility, reduced risk, and overall improved quality,” DeRam said.

Kyle Rose, president at Rook Quality Systems, described Halo as a game-changer for medical device compliance.

“Halo for Change Management automatically gathers all of the quality data and documents that may be impacted by a change and presents it to the user to clearly identify the scope of the change,” Rose said. “This is one of the hardest compliance issues to manage manually and will greatly improve efficiency for all Greenlight Guru users.”