- Risk Management Software -
greenlight.guru's risk management feature set is engineered to keep your risk management file living throughout your entire product's lifecycle. It's the only eQMS built to follow ISO 14971.
By integrating the risk management process into your entire quality management system, you can fix issues that expose you to risk when it’s less expensive and time-consuming to do so. Risk management will no longer be a discouraging process with little visibility.
Link risk management to your product development design control traceability matrix, toggle between design and risk with a single click and use risk management together with design controls to mitigate issues before they become problems.
Use this criteria and terminology to apply consistent classification of risk across the board. Risk levels are then automatically evaluated based on your criteria and used to populate your risk acceptability matrix -- providing more visibility into risk.
When a project is complete and in production, keep your risk management file up-to-date and living throughout the entire lifecycle by electronically reviewing, signing, and approving documentation with a single source of truth.
“Compliance-related stress levels are down, and we seem to have a bit more "clout" when dealing with competitors, partners, compliance testing labs, etc. because greenlight.guru has enabled us to have better compliance-related conversations.”
“greenlight.guru has made the design control and risk management process extremely easy to understand and explain to people not familiar with the process and helped them to understand how all of the steps are linked.”
“We dug deeper to see how other friends we knew were handling their QMS needs, and after adding up time, consultant fees, etc. we felt greenlight.guru was the right tool for the job.”
Speak with a medical device quality management expert and see
greenlight.guru in action.