Integrate risk-based thinking into all your design and development processes to comply with the new risk-based changes to ISO 13485:2016.
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.
Identify, mitigate, and prevent potential risks as early as possible.
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.
Get a complete and accurate picture of risk across products, processes and teams.
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.
Identify risk acceptability criteria with an easy to use graphical interface that ties into your design control matrix.
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.
Easily link and connect design controls and documents as risk control measures to mitigate and reduce risks throughout the entire product lifecycle.
Conduct risk analysis evaluation in a traceable system, capturing and recording relevant data throughout the design and development process.
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.”