“Our strange height revolutionized a medical device pattern attention by relocating pattern controls off of paper and into a cloud,” says Greenlight Guru co-founder and CEO David DeRam.
May 07, 2018
Greenlight Guru, a usually cloud-based peculiarity government program privately for medical device companies, is gratified to announce Multi-Level Design Control, a latest chronicle of a purpose-built medical device pattern traceability software.
“Our strange height revolutionized a medical device pattern attention by relocating pattern controls off of paper and into a cloud,” says Greenlight Guru co-founder and CEO David DeRam. “Now we are holding a subsequent step and adding functionality to a height for multi-level pattern controls for medical inclination with mixed sub-systems and components, as good as Software as a Medical Device (SaMD) products.”
Multi-Level Design Control will concede medical device manufacturers to improved conduct components or sub-components by introducing hierarchical workflows.
This will concede product expansion teams to have a some-more structured, holistic perspective 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, permitting manufacturers to improved daydream their hardware, firmware and program components, including software-only offerings ordinarily found on smartphones and smartwatches.
“The initial recover of a Design Control program was a game-changer for traceability,” says Greenlight Guru owner and VP of QA/RA Jon Speer. “Multi-Level Design Control takes advantage of a latest technologies to concede manufacturers to not usually say FDA and ISO correspondence though put their concentration precisely on Quality while building a subsequent era of medical devices. Medical inclination customarily have mixed components that have opposite pattern and prolongation cycles that need to be managed separately. Multi-Level Design Controls concede for finish togetherness in digital workspaces to serve assist product quality.”
Greenlight Guru is also announcing an refurbish to “The Ultimate Guide to Design Controls for Medical Device Companies” that incorporates a latest regulatory developments, workflows and best practices.
This product refurbish follow Greenlight Guru’s record-breaking expansion in Q4 2017. For a demo of a new Multi-Level Design Control underline set with a medical device guru, greatfully revisit http://www.greenlight.guru/design-control-software.
About Greenlight Guru
Greenlight Guru is a usually peculiarity government height designed privately for medical inclination companies. The height helps companies get safer products to marketplace faster, simplifies FDA and ISO regulatory correspondence and provides a singular source of law by joining a government of all peculiarity processes like CAPAs, risk, audits and more. Greenlight Guru’s height is used by thousands of users opposite a creation to pull over baseline correspondence achieving True Quality. For some-more information, revisit http://www.greenlight.guru.