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.

 

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

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