Greenlight Guru Announces Multi-Level Design Control Software

May 7, 2018

Functionality enables visibility into multiple workspaces, holistic view of design components and a centralized workspace with real-time updates


INDIANAPOLIS — May 7, 2018 — Greenlight Guru, the only cloud-based quality management software specifically for medical device companies, is pleased to announce Multi-Level Design Control, the latest version of its purpose-built medical device design traceability software.

“Our original platform revolutionized the medical device design industry by moving design controls off of paper and into the cloud,” says Greenlight Guru co-founder and CEO David DeRam. “Now we are taking the next step and adding functionality to our platform for multi-level design controls for medical devices with multiple subsystems and components, as well as Software as a Medical Device (SaMD) products.”

Multi-Level Design Control will allow medical device manufacturers to better manage components or sub-components by introducing hierarchical workflows.

This will allow 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.”

Greenlight Guru is also announcing an update to “The Ultimate Guide to Design Controls for Medical Device Companies” that incorporates the latest regulatory developments, workflows and best practices.

This product update follows Greenlight Guru’s record-breaking growth in Q4 2017. For a demo of the new Multi-Level Design Control feature set with a medical device guru, please visit


About Greenlight Guru

Greenlight Guru is the only quality management software platform designed specifically for medical devices companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru’s platform is used by thousands of users across the globe to push beyond baseline compliance achieving True Quality.

quality management system QMS design control software medical devices

Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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