Greenlight Guru, a provider of cloud-based software for med-tech companies, has launched Risk Solutions, a complete risk management software that pairs AI-generated insights with risk management workflows.
According to the 2023 MedTech Industry Benchmark Report, one of the top challenges cited for managing design and development activities was implementing risk control measures. Greenlight Guru’s Risk Solutions provides a smarter way for Medtech teams to manage risk for their device(s) and business. The technology consists of two components:
● Risk Intelligence helps users identify and assess the most relevant risks for their devices using AI and advanced statistical models powered by real-world data to provide insights and recommendations for their device(s).
● Risk Management provides collaborative workflows for creating risk matrices and documenting risk. It is the only solution in the industry that aligns with ISO 14971:2019 while providing complete traceability throughout the entire device lifecycle.
“Risk assessments are a fundamental part of bringing safe medical devices to market,” says Tyler Foxworthy, chief data scientist of Greenlight Guru. “Historically, risk assessment has been a complex, heuristically driven process for teams. Our goal with Risk Intelligence is to make that process better and more comprehensive for our customers by making relevant risk data and long-established statistical risk assessment models more accessible and less intimidating.”
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Greenlight Guru’s novel search engine leverages machine learning and natural language processing to aggregate industry data from sources like the FDA MAUDE database. With applied statistical models and AI, Risk Intelligence enables searches by product codes, indications for use, and intended use to identify and recommend potential risks.
Greenlight Guru’s customers are eagerly anticipating the new Risk Intelligence solution, according to Brad Cunningham, director of quality assurance from Pirouette Medical. Cunningham says, “This will save lots of time normally spent brainstorming, researching, and documenting hazards, patient harms, and trying to estimate probabilities and severities. I enjoy that we can combine our existing expertise with AI-driven insights derived from regulatory databases to best evaluate risk for our device.”
Additionally, Greenlight Guru’s enhanced Risk Management software includes features like in-line editing for creating and documenting risk activities, auto-calculated estimated risk probabilities, and continuously updated IMDRF codes.
“Managing risk is a critical and continuous activity for medical device companies,” says David DeRam, CEO of Greenlight Guru. “We’ve heard from many of our medical device customers over the years that no single solution helps them ensure compliance and consistency throughout their device lifecycle. We set out to fix that with the new Risk Solutions by providing the only ISO 14971-aligned system along with AI-powered insights. This is the biggest advancement in the industry since we launched our original eQMS over 10 years ago. We are excited to share this revolutionary technology to help our customers build innovative medical devices that improve the quality of life.”