Greenlight Guru, a supplier of cloud-based software program for medtech corporations, has launched Danger Options, a whole danger administration software program that pairs AI-generated insights with intuitive danger administration workflows. 

In line with the 2023 MedTech Trade Benchmark Report, one of many prime challenges cited for managing design and growth actions was implementing danger management measures. Greenlight Guru’s Danger Options offers a better approach for medtech groups to handle danger for his or her gadget(s) and enterprise. The answer consists of two elements:

  • Danger Intelligence helps customers establish and assess probably the most related dangers for his or her units utilizing AI and superior statistical fashions powered by real-world knowledge to supply insights and proposals for his or her gadget(s).
  • Danger Administration offers visually intuitive, collaborative workflows for creating danger matrices and documenting danger. It’s the solely resolution within the trade that aligns with ISO 14971:2019 whereas offering full traceability all through the whole gadget lifecycle.

Tyler Foxworthy, chief knowledge scientist of Greenlight Guru, stated: “Danger assessments are a basic a part of bringing secure medical units to market. Traditionally, danger evaluation has been a posh, heuristically pushed course of for groups. Our purpose with Danger Intelligence is to make that course of higher and extra complete for our clients by making related danger knowledge and long-established statistical danger evaluation fashions extra accessible and fewer intimidating.”

Greenlight Guru’s search engine leverages machine studying and pure language processing to combination trade knowledge from sources just like the FDA MAUDE database. With utilized statistical fashions and AI, Danger Intelligence allows searches by product codes, indications to be used, and supposed use to establish and suggest potential dangers.

In line with Brad Cunningham, director of high quality assurance from Pirouette Medical: “This may save plenty of time usually spent brainstorming, researching, and documenting hazards, affected person harms, and attempting to estimate chances and severities. I get pleasure from that we will mix our present experience with AI-driven insights derived from regulatory databases to greatest consider danger for our gadget.”

Greenlight Guru’s Danger Administration software program consists of intuitive and time-saving options, like in-line modifying for creating and documenting danger actions, auto-calculated estimated danger chances, and repeatedly up to date IMDRF codes. The result’s a robust resolution for medtech corporations to enhance their danger administration course of, drive extra effectivity and confidence, and in the end get safer units to market.

David DeRam, CEO of Greenlight Guru, stated: “Managing danger is a essential and steady exercise for medical gadget corporations. We’ve heard from lots of our medical gadget clients over time that no single resolution helps them guarantee compliance and consistency all through their gadget lifecycle. We got down to repair that with the brand new Danger Options by offering the one ISO 14971-aligned system together with AI-powered insights. That is the most important development within the trade since we launched our authentic eQMS over ten years in the past. We’re excited to share this revolutionary know-how to assist our clients construct modern medical units that enhance the standard of life.”