Medical Device Risk Management Software

Integrated and Compliant Risk Management

Greenlight Guru eases audit stress with a Risk Management workspace offering full traceability with the rest of your QMS. Seamlessly integrate risk-based thinking across your device ecosystem for effortless compliance with ISO 14971:2019 and ISO 13485:2016.

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1,100+ of the world’s leading MedTech companies trust Greenlight Guru.

Risk

A Risk You Don’t Have To Accept

Risk management can be a difficult process. Regulations like ISO 14971:2019 make it easier for MedTech companies.

Too many companies find themselves falling short and wasting time on connecting their design controls with risk management or ensuring that risk management is a living process throughout the entire product lifecycle. For all these reasons, we developed Greenlight Guru.

The Only ISO 14971 Aligned Risk Management Software For MedTech

Leverage Greenlight Guru’s Risk Management Software to integrate risk throughout the entire product lifecycle and ensure compliance.

Use Risk Management as an Asset

Discover, mitigate, and prevent potential risks as early as possible.

Integrate and Connect Risk Throughout

Get a complete and accurate picture of risk through pre-market and post-market surveillance stages.

Define Your Risks

Identify risk acceptability criteria with an intuitive graphical interface tied to your design control matrix.

Manage Your Risk Control Processes

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

Effective Risk Management Doesn’t Need To Be Complex

Designed specifically for the MedTech industry with simplicity and flexibility in mind.

Link and connect design controls and documents as risk control measures to mitigate and reduce risks throughout the entire device lifecycle.

Build and manage your Risk Matrices with more ease and clarity than ever before.

Leverage configured extensive list of International Medical Device Regulators Forum (IMDRF) codes to document hazards and patient harms. Easily configure and update the list to best suit your needs.

Streamline risk reviews and easily trace documentation throughout your design and development process, crafting a robust, audit-ready Risk Management File with ease.

Ensure consistent classification of risk across the risk project. Risk levels are then evaluated based on your set criteria.

Designed With Your Entire Organization in Mind

Benefits for Teams

Risk touches every part of your medical technology products, so we make sure that our solution does too.

For Product

Improve the quality, safety, and effectiveness of your medical devices
Establish connections between design controls and risk management
Demonstrate a risk-based approach to design with full traceability to related design controls and components

Designed With Your Entire Organization in Mind

Benefits for Teams

Risk touches every part of your medical technology products, so we make sure that our solution does too.

For Quality

Ensure your risk management efforts are holistic and documented
Maintain compliance with industry standards and requirements
Use a risk-based process to improve quality throughout the device lifecycle

For Leaders

Ensure there are adequate and appropriate resources for conducting risk management activities
Bring safer devices to market by proactively managing risk
Define and activate your company’s risk management policy and risk acceptability criteria

risk management process total product lifecycle

Integrate Risk-based Thinking Into Your Entire Quality Ecosystem

Risk management is a total product lifecycle process. When a project is complete and in production, keep your risk management file up-to-date throughout the entire lifecycle by electronically reviewing, signing, and approving documentation with a single source of truth.

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AI-Powered Risk Intelligence

Intelligence Meets Compliance

Work more efficiently, enhance risk assessments, and keep patient safety at the heart of what you do with our first-of-its-kind technology.

Risk Intelligence gives you AI-powered insights to help you identify the most relevant device hazards and patient harms with real probabilities and severities for your devices based on real-world adverse event data.

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Are You Ready to Experience the Greenlight Guru Difference?

Get a deep dive into our Risk Management Software, ask questions, and see your risk matrix come to life.

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50 %

Reduction in time spent on design documentation

35 %

reduction in time to market

35 %

Reduction in hours needed per recall or adverse event