FDA has partnered with Greenlight Guru on a webinar series to spread awareness for FDA’s Case for Quality program and how the regulatory paradigm is shifting.
The old world

Disconnected systems and lack of visibility lead to increased risk.

Relying on a general purpose QMS for your medical device quality system leaves you exposed to compliance complexities and regulatory roulette.

The world with Greenlight Guru

A connected quality ecosystem lets you see what you've never seen.

Our software connects disparate processes, sources, people, and data for the first time ever. Increased visibility smooths your path to compliance and puts True Quality within reach.

Increase visibility and control risk

Greenlight Guru is the only quality management software designed specifically for the medical device industry.

Greenlight Guru's Solution

Quality Management Software. Industry-Leading Expertise.
Our Premarket Quality Management Software helps you set the right foundation to bring safer, high-quality medical devices to market faster.
Our Postmarket Quality Management Software provides visibility that decreases risk so you can advance the success of your medical devices.
Our Quality Management Experts help you establish and advance a quality culture throughout your entire device lifecycle.

Explore Our Software

Explore our Services

True quality eases the fear of noncompliance and embraces quality as a business accelerator.




"We adopted Greenlight Guru 18 months ago to build our QMS. We recently passed our ISO 13485 Stage 2 audit, due in part to the ability to demonstrate a comprehensive matrix of risk and design controls. Demonstrating our QMS using GG was fundamental in this achievement. I'll also say that the team at GG has been a phenomenal resource and support for us. I never feel like I'm weeding through the quagmire of compliance alone, they are part of our team."


Are you interested in learning more about our Quality Management Software? Let’s take Greenlight Guru on a demo.

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Featured Resources

FDA's Case for Quality: Voluntary Program and Status Update (Part 2 of 4)

FDA's Case for Quality: What, Why and How? Changing the Regulatory Paradigm

Greenlight Guru has partnered with FDA to give you the inside track on what you need to know about the Case for Quality, the changing regulatory paradigm, and what all this means for all stakeholders involved with the medical device industry.

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

"I was actually a little nervous going into the audit, because it seemed too effortless."