Greenlight Guru's State of Medical Device Product Development and Quality Management 2020 Report is here.

Risk Management Software

The only risk management solution that aligns directly with ISO 14971.

Greenlight Guru reduces the stress of audits and inspections by integrating risk-based thinking into your entire quality ecosystem keeping you in compliance with all the new risk-based changes to ISO 13485:2016.


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Use Risk Management as a Tool

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.


Link Risk Management to Design & Development Activities

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.

Create Your Risk Acceptability Matrix

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.


Manage Your Risk Control Process

Easily link and connect design controls and documents as risk control measures to mitigate and reduce risks throughout the entire product lifecycle.

Paperless, Living Risk Management File

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.

August 7, 2017
“Fantastic Product and Even Better Team”
The GG team goes out of their way to help us meet our business objectives. They are knowledgeable in the regulatory and quality management space and are always trying to improve their software and user experience.
Ryan Shelton
Validated Reviewer
Verified Current User


Want to learn more about our Premarket Quality Management software? Let us show you around Greenlight Go.

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