Greenlight Guru, a leading provider of cloud-based software solutions for Medtech companies, announced a new partnership with HTEC Group, a global digital product development and engineering services firm, to further modernize the architecture for its quality management software.

The medical device sector has faced a number of challenges in the development of new medical devices. Though some are related to the volatile economic climate, medical device manufacturers also must comply with increasingly complex regulatory requirements. In the 2023 MedTech Industry Benchmark Report, findings show that 1 in 3 medical device organizations say they are not well equipped to meet regulatory and product development objectives in 2023.

In order to ensure medical device manufacturers stay ahead of the curve in an ever-expanding industry, Greenlight Guru and HTEC will develop a new, innovative architecture that allows its end-users to complete regulatory and compliance processes faster and more efficiently. The system is projected to enable over 1,000 Greenlight Guru customers—ranging from startups to enterprise medical device manufacturers—to continue bringing high-quality, safe, life-changing medical devices to market.

“As part of a shared commitment to deliver positive health outcomes globally, this technology collaboration between HTEC and Greenlight Guru creates the opportunity to advance medical device quality management,” says Pete Plotas, vice president of global alliances at Greenlight Guru. “This ultimately helps medical device companies improve the quality of life for their customers by providing them with modern software solutions that are designed to bring the highest quality products to market faster.”

Backed by their long-term experience building next-gen medical devices and deep understanding of regulatory frameworks, HTEC is assisting Greenlight Guru in improving their existing eQMS solution. By leveraging HTEC’s modular approach to software development, HTEC developed a more scalable, smarter, and resilient modern architecture.

“Through our expanded partnership with Greenlight Guru, we are not only given a unique opportunity to leverage our deep domain knowledge to advance their existing QMS solution and help their customers and other medical organizations drive medical device innovation, but also collaborate with one of the world-leading providers of a cloud-based quality management software,” says Dejan Pokrajac, director of engineering and delivery at HTEC Group

The announcement comes on the heels of Greenlight Guru’s launch of its new Export API, which allows customers to connect quality system data with other third-party software.