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A modern eQMS for product-led,
fast-moving medtech innovators.

Built to fit your process, not force it
Stay focused on product, not paperwork
Built for engineers and trusted by auditors

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Greenlight Guru Ultralight today.

An eQMS for product-led,
fast-moving medtech innovators.

Flexible to support how you work
Help engineers stay compliant as they build
Integrates with your existing tech stack

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An eQMS for established and
expanding medtech teams.

Guardrails to guide your team
Built for global scale
Audit-tested quality workflows

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Data collection and management
designed for medtech clinical trials.

No-code setup for any study type
A single platform for all your studies
Facilitating ISO 14155 and 21CFR Part 11 compliance

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Get a personalized demo of
Greenlight Guru Clinical today.

Why Us

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Resources

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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 Intelligence For MedTech

AI-powered Insights to Revolutionize Risk

Greenlight Guru’s Risk Intelligence provides AI-generated insights from industry databases so MedTech teams can proactively identify, document, and mitigate risk with more accuracy throughout the device lifecycle.

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1,000+ of the world’s leading MedTech companies trust Greenlight Guru.

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A New Approach to Risk Management

Assessing risk can be a challenge due to inconsistent data and limited access to research. This can lead to uncertainty and gaps in your assessment of device hazards and patient harms and probabilities of occurrence.

Greenlight Guru’s Risk Intelligence provides the necessary data to improve your work and make informed decisions quickly.

First-of-its-kind Intelligence for Risk

Greenlight Guru’s Risk Intelligence leverages AI and proven statistical models that help you predict the most relevant risks for your devices.

Save Time and Resources

Reduce the amount of time spent on cumbersome research and guesswork by using AI-generated data from FDA databases

Accelerate Timelines

Work more effectively with AI so you can spend more time designing for better patient outcomes

Increase Confidence

Eliminate uncertainty in risk estimation with calculations based on real data and confidence intervals.

Design Safer, Better Devices

Capture and assess hazards and patient harms missed by other medical device manufacturers

This will save lots of time normally spent brainstorming, researching, documenting hazards and patient harms, and trying to estimate probabilities and severities. I love that Risk Intelligence lets us combine our existing expertise with AI-driven insights derived from FDA databases to best evaluate risk for our device.

Brad Cunningham

Director of Quality Assurance | Pirouette Medical

Drive Effective, Efficient, and Confident Risk Management

Access data tailored to your device.

Search by product code or Global Medical Device Nomenclature (GMDN) terms to generate a provisional risk matrix and interactive data visualizations.

Predict device risk.

Identify and predict the most relevant hazards and patient harms paired with estimated probabilities and severities generated by advanced statistical models and real-world adverse event data.

Put insights into action.

Jumpstart the risk management process by taking these insights into a modern digital solution to inform and build your risk matrix and maintain your risk management files.

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Risk Solutions for MedTech

Building and evaluating Risk across the device lifecycle is a challenging process. Accelerate this crucial task by integrating Risk Intelligence with your Risk Management.

Make informed, data-driven decisions to optimize risk management throughout your device lifecycle.

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Integrated and Compliant Risk Management

Greenlight Guru provides you with an ISO-14971-aligned Risk Management workspace that enables 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 Assess Risk

Manage some of the most critical activities of medical device development with confidence and efficiency and leave the dread of handling risk in the past.

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