Greenlight Guru, a Medical Device Quality Management Software (MDQMS) platform, has teamed up with Emergo by UL, a consulting firm specialising in global medical device regulatory compliance.
Together, the two companies will aim to offer an all-in-one quality management and regulatory affairs solutions package for medical device companies which are looking to grow and scale globally.
Medical device companies will gain access to Greenlight Guru’s modern, cloud-based MDQMS platform and Emergo’s consulting services and cloud-based Regulatory Affairs Management Suite (RAMS). Greenlight Guru’s MDQMS platform enables closed-loop quality traceability for real-time audit readiness, while accelerating product development activities. Emergo by UL consultants help companies implement and maintain quality systems to ensure medical device 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 co-ordinate registrations and renewals.
This partnership aims to help medical device manufacturers to bring devices to market faster, and as a result, ensure success in a fast-changing industry. The strategic alliance will be fully operational by May 13th, 2020.
David DeRam, CEO of Greenlight Guru commented: “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.
“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.”
Together, the partnership will allow organisations 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 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).
Michael Van Der Woude, director and general manager of Market Access at Emergo by UL said: “This relationship will help medical device companies establish a modern, integrated approach to quality and regulatory system strategy.
“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 organisations navigate global regulatory changes with ease throughout the coming decade.”
This news follows enhancements to Greenlight Guru’s Change Management and Risk Management workflows, the launch of Digital Design Reviews, and the company’s sixth consecutive quarter as a G2 Crowd market leader in the quality management software category. Additionally, Emergo by UL recently launched Smart Builder market access tools for the RAMS platform, enabling automated preparation of documentation necessary for US FDA 510(k) and European MDR Technical File submissions.