Greenlight Guru Launches New Tool for Medical Device Closed-Loop Traceability

According to a recent announcement, Greenlight Guru, a medical device quality management software (MDQMS) platform, has launched “Visualize,” a new machine learning-enabled tool that the company says will redefine how medical device manufacturers approach closed-loop traceability.

Medical device professionals often rely on human experience knowledge and manual processes to understand equipment tracing. As the complexity of the quality system grows, this can lead to stress for those managing the system, productivity loss, and increases the likelihood of regulatory problems and recalls.

Greenlight Guru says Visualize is designed to provide a platform for users to achieve closed-loop traceability through a connected quality ecosystem. The machine learning capabilities reportedly allow medical device companies to see, understand, and interact with the relationships and connectedness of their quality system in a way that was previously impossible.

“Today, 45 percent of medical device professionals cannot demonstrate closed-loop traceability in their quality system, and of those that are able to, one in three still say it takes substantial effort to do so, which is astonishing considering the implications. Visualize allows medical device professionals to eliminate human error, uncover the downstream impacts of change, gain full visibility into quality data trends, and reduce the cost of poor quality by making better quality-driven decisions,” said David DeRam, CEO, Greenlight Guru. “Visualize is a new paradigm in how you see, explore, understand, and communicate the world of quality — and it’s only the beginning.”

According to the release, the following machine learning (ML) driven capabilities are available:

• ML-powered relationship creation and virtual linking of all related items within the QMS
• A visual traceability pop-up map accessible on-demand to show all linked or related items
• Transparency into the bridging of relationships between items in the QMS
• Navigation into the related items to see where else they are used in the QMS
• Multi-tiered filtering capabilities to customize the user’s view of QMS data

“There are so many inputs, outputs, independent and interdependent activities, that the ability to achieve transparency and visibility into the relationships within our QMS is invaluable,” said Morris Sherwood, Regulatory Compliance, Zyris Dental. “Visualize gives me that picture and allows me to be more successful, more effectively communicate this world to my colleagues, and provides a way to process quality information more expeditiously. ”