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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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Risk Solutions For MedTech

A New Era of Risk Management is Here

Improve the risk management process with a first-of-its-kind, complete risk management software. Leverage AI-generated insights with intuitive workflows, aligned with ISO 14971:2019, for streamlined compliance and reduced risk throughout the entire device lifecycle.

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

Risk Solutions

Transform The Way You Manage Risk

The data required to accurately predict risk is often inconsistent and hard to access, leaving companies guessing when it comes to assessing risk. With Greenlight Guru Risk Solutions, you get this at your fingertips. 

Integrating and documenting risk across the device lifecycle is no easy feat, whether you’re creating Risk Management Files for the first time or managing risk alongside post-market surveillance activities.

 
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Where Intelligence Meets Compliance

A complete solution to provide a better way for risk management. Put AI-powered insights into action for streamlined compliance and reduced risk.

 

Risk Intelligence

A New Approach to Risk

Avoid the countless hours, cycles, and dollars researching adverse events and guessing probabilities of risk.

With the power of Greenlight Guru’s Risk Intelligence, identify and predict the most relevant device hazards and patient harms with estimated probabilities and severities for your devices, based on real-world adverse event data. 

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Risk Management Software

Integrated and Compliant Risk Management

Greenlight Guru reduces the stress of audits and inspections by providing you with the only ISO-14971-aligned Risk Management software that demonstrates complete traceability with the rest of your QMS.

Integrate risk-based thinking into your entire device ecosystem, keeping you in compliance with ISO 14971:2019 and the risk-based requirements of ISO 13485:2016.

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Experience A Better Way to Manage Risk

Leverage the power of Risk Solutions to make better, data-informed decisions and streamline how you integrate risk throughout your device lifecycle. 

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Introducing Risk Solutions: A New Era in Risk Management for MedTech

In our day-to-day lives, most of us manage risk in a pretty haphazard fashion. Decisions to put on a seatbelt or reapply sunscreen after a few hours on the beach aren’t made with...

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Live Product Launch Event | Welcome to A New Era of Risk Management

Witness the unveiling of Greenlight Guru's Risk Solutions and see for yourself how Greenlight Guru is revolutionizing the way you manage risk — and how it’ll transform the way you work.

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Greenlight Guru Launches AI-Powered Solutions for Better Risk Management for MedTech

First-of-its-kind Risk Solutions pairs AI-generated insights with the only intuitive and ISO 14971:2019 compliant risk management software to help...

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