Indianapolis, Indiana – Multi-Level Design Control is Greenlight Guru’s latest version of its purpose-built medical device design traceability software.
Multi-Level Design Control allow medical device manufacturers to better manage components or sub-components by introducing hierarchical workflows.
This allows product development teams to have a more structured, holistic view of their design’s components, providing a centralized workspace with real-time updates. Furthermore, Multi-Level Design Control incorporates Software as a Medical Device (SaMD) controls, allowing manufacturers to better visualize their hardware, firmware and software components, including software-only offerings commonly found on smartphones and smartwatches.
“The first release of our Design Control software was a game-changer for traceability,” says Greenlight Guru founder and VP of QA/RA Jon Speer. “Multi-Level Design Control takes advantage of the latest technologies to allow manufacturers to not only maintain FDA and ISO compliance but put their focus squarely on Quality while developing the next generation of medical devices. Medical devices routinely have multiple components that have different design and production cycles that need to be managed separately. Multi-Level Design Controls allow for complete unity in digital workspaces to further expedite product quality.”