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Class I-III? We’re Here To Help.

No matter your classification, everything begins with an idea. Whether you plan on submissions with the FDA or EU MDR, you need an end-to-end QMS solution designed specifically for MedTech. Don’t settle for less.

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This Work Is Hard. We’ll Make Your Job Easier.

Starting off with the right foundation to develop high-quality devices is challenging. It’s easy to lose sight of creating a culture that values excellence and quality when you’re juggling funding, regulatory, design, product development, laboratory procedures, growing markets, competitors, and rapidly growing technology. All these areas can become roadblocks if not managed properly in an end-to-end system.

800+ of the world’s leading MedTech companies trust Greenlight Guru.

Your Device
Classification Matters

Whether you are submitting to the EU, FDA, Health Canada, or others, your path to market and steps to success are determined by your classification and requirements that follow. Getting started with a world-class QMS tailored to your device type is the best way to align with regulatory guidelines.

Designed For The MedTech Industry

Get a deep dive into our software, ask questions, and see your product lines come to life.

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