Risk Management Software

The only cloud-based risk management solution
that aligns with ISO 14971

With risk management built into every feature, FDA inspections and ISO audits are stress free.


Comply with ISO 14971 - the Risk Management Standard

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.

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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.


Everything you need for your risk management and compliance requirements

Aligned with ISO 14971
Link Design Controls & Risk Management
Determine Harm
Link Risk-Benefit Analysis
Risk Level Charts
Identify Hazards
Estimate and Evaluate Risks
Automated Risk Evaluation
Living Risk Management File
Identify Hazardous Situations
Identify Risk Controls
Update Residual Risk

Customer References

"Compliance stress... down..."

“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.”

-Jon Gardner R&D Engineer CardioQuip

"...easy to understand..."

“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.”

-Rian Wendling Director of Regulatory Affairs SimplicityMD

"...the right tool for the job..."

“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.”

-Gabriel Sanchez CEO Zebra Medical Technologies

Speak with a medical device quality management expert and see
Greenlight Guru in action.

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