Greenlight Guru and Emergo by UL Announce Bundled Offerings
Greenlight Guru and Emergo by UL entered an alliance to enable medical device companies with turn-key packages for implementing a digital-first approach to quality management alongside a regulatory affairs smart builder & insights to accelerate device clearance timelines and global market access.
This strategic alliance creates automated capabilities for medical device manufacturers to bring devices to market faster, and helps ensure success in a fast-changing industry.
Furthermore, the joint offerings will allow organizations to:
Streamline and automate device design documentation and quality processes in alignment with major industry regulations and standards such as ISO, FDA, EU MDR, & 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 bench of QA/RA experts with insights and best practices from across the medical device industry, including mechanical and electromechanical devices, IVDs and digitally-enabled products such as Software as a Medical Device (SaMD)
