Greenlight Guru teamed up with EMERGO by UL to offer an all-in-one quality management and regulatory affairs solutions package for medical device companies seeking to grow and scale globally. Services will be operational in mid-May.
Through this alliance, companies gain access to Greenlight Guru’s cloud-based medical device quality management software (MDQMS) platform and EMERGO by UL’s Quality Management System (QMS) consulting services and cloud-based Regulatory Affairs Management Suite (RAMS). Greenlight Guru’s MDQMS supports closed-loop quality traceability for real-time audit readiness, while accelerating product development. EMERGO by UL consultants help companies implement and maintain quality systems to ensure regulatory compliance across more than 20 markets, and RAMS provides digital tools to manage registration and certification documents, monitor the latest regulatory updates, as well as coordinate registrations and renewals.
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 and MDSAP
- Easily discover and access regulatory requirements by market
- Automate the generation of error-free FDA 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)
“This relationship will help medical device companies establish a modern, integrated approach to quality and regulatory system strategy,” said Michael Van Der Woude, Director & General Manager of Market Access at EMERGO by UL. “I am confident that our expertise in combination with Greenlight Guru’s MDQMS platform will not only create peace of mind but also stimulate growth and help organizations navigate global regulatory changes with ease throughout the coming decade.”
“Legacy-based systems are all too common in the medical device industry; however, building a quality management system from scratch or phasing out an old system can be a daunting task,” said David DeRam, CEO of Greenlight Guru. "Our relationship with EMERGO by UL seeks to streamline this process by pairing Greenlight Guru’s purpose-built quality management system alongside EMERGO by UL’s award-winning consulting services.”