Alliance with Emergo

Alliance Announcement

Greenlight Guru and Emergo by UL have teamed up to provide medical device companies with a complete solution for digital-first quality management and regulatory affairs. This alliance aims to accelerate device clearance timelines and global market access through turn-key packages and smart builder tools.

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"Helping medical device companies establish a modern, integrated approach to quality and regulatory system strategy."

The joint offerings will allow organizations to:

Streamline and automate device design documentation and quality processes to meet regulatory standards such as ISO, FDA, EU MDR, and MDSAP.
Easily discover and access regulatory requirements by market
Automate the generation of error-free 510(k) submissions
Manage and monitor device registrations globally
Assure real-time audit readiness
Simplify market access and drive revenue growth with global in-country representation
Access a team of QA/RA experts with insights and best practices across the medical device industry, including mechanical devices, IVDs, and SaMD.