Greenlight Guru has launched the world’s first artificial intelligence (AI) and machine learning recommendation engine for medical device quality.

The Halo for Change Management engine offers recommendations to quality and product teams on items impacted by a change order and real-time visibility required to find, analyse, and handle the impact of a change.

Currently, finding every document affected by a proposed change order and interpreting their impact is a tiresome, error-prone procedure, Greenlight Guru noted.

The medical device quality management software (MDQMS) platform said that without complete visibility and strategic understanding, many companies react to change because of siloed information, rigorous searches, and high risk from missing important assets.

Greenlight Guru CEO David DeRam said: “Our recent 2021 State of Medical Device Quality Report revealed that currently, 60% of organisations 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.

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“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.”

The recommendation engine uses AI and machine learning capabilities to predict downstream impacts and collect actionable recommendations to metamorphose the change management process, which is beyond the human capacity.

By using the product, organisations will not have to jeopardise compliance by changing or referencing various change orders during an audit.

Furthermore, teams can allocate more time to design quality products and less for the paperwork.

The solution replaces reactivity with predictability and provides seamless traceability.