Multi-level design control allows medtech manufacturers to introduce hierarchical workflows. Image courtesy of Greenlight Guru.
Greenlight Guru — which offers cloud-based quality management software specifically for medical device companies — recently announced Multi-Level Design Control, the latest version of its purpose-built medical device design traceability software.
The new platform improves on Indianapolis-based Greenlight Guru’s previous offering that moved design controls off the paper and into the cloud, said Greenlight Guru co-founder and CEO David DeRam.
“Now we are taking the next step and adding functionality for multi-level design controls for medical devices with multiple subsystems and components, as well as Software as a Medical Device (SaMD) products,” he said in a press release.
The product is designed to help medical device manufacturers better manage components and sub-components by introducing hierarchical workflows. Design teams will be able to create a more structured and holistic view of design components and a centralized workspace with real-time updates. In addition, the platform incorporates SaMD controls so that manufacturers can visualize hardware, firmware, and software components, including software-only offerings commonly found on smartphones and smartwatches.
Jon Speer, co-founder and VP of QA/RA for the company, said the traceability matrix was due for a change. “Medical devices routinely have multiple components that have different design and production cycles that need to be managed separately. Design Control 2.0 takes advantage of the latest technologies to allow manufacturers to maintain FDA and ISO compliance while developing the next generation of medical devices.”
Greenlight Guru will be rolling out Design Control 2.0 to customers in the second and third quarters of 2018, with complete implementation by the end of the year. The company had also updated it’s guidance documents for medical device companies to incorporate the latest regulatory developments, workflows, and market tools.
