Expanded partnership will galvanize MedTech companies’ push to improve the quality of life.
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.
Indianapolis, IN – April 27, 2023 – Greenlight Guru, the leading provider of cloud-based software solutions for MedTech companies, today 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.
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 1000 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. 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.
– Pete Plotas
Vice President of Global Alliances at Greenlight Guru
Backed by their long-term experience building next-gen medical devices and deep understanding of regulatory frameworks, HTEC is assisting Greenlight Guru improve their existing, industry-leading eQMS solution. By leveraging the 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.
– Dejan Pokrajac
Director of Engineering and Delivery Lead at HTEC Group
With the increasing adoption of SaMD and AI in particular in the health care equation, regulatory bodies’ approaches are shifting from traditional to more innovative. The FDA is evaluating the manufacturer’s quality culture and organizational excellence, as well as their commitment to monitoring the real-world performance of their products once they reach the US market. This is especially true for solutions that employ adaptive AI technologies. This is why trust in quality management systems is more than just a regulatory requirement for medical device manufacturers; it is the lifeline that ensures safety, accuracy, and reliability – because patient lives are not a variable; they are the constant we strive to safeguard. We provide trust to medical device makers in collaboration with GreenLight Guru. Trust that by adhering to the established QMS, regulatory compliance will not be an afterthought but a byproduct of excellence.
– Milos Cigoj
Healthcare and Life Science Quality and Compliance Lead at HTEC Group
The announcement comes at 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.
About HTEC Group
HTEC Group is a global, digital, product development and engineering services firm powering the technological evolution of the world’s most impactful organizations – from disruptive startups to Fortune 500 companies. With more than 2,000 experts spread across Central and Southeast Europe and consulting, innovation, and product design offices in Silicon Valley, New York, and London and extensive experience across business domains – including Healthcare, Retail, Transportation and Smart Mobility, Logistics, FinTech, Green Energy, Media, and Deep Technology – HTEC is both an ideal technology partner for its clients and the ultimate growth platform for its employees.
About Greenlight Guru
Greenlight Guru is the leading connected, cloud-based platform purpose-built for MedTech companies. The end-to-end solution streamlines product development, quality management, and clinical data management by integrating cross-functional teams, processes, and data throughout the entire product lifecycle. Greenlight Guru’s platform is used by organizations across the globe that are replacing their disjointed, legacy tools and solutions to bring life-changing products to people faster, and with less risk. For more information, visit https://www.greenlight.guru.
To learn more about how we help medical companies drive innovation in Healthtech space, reach out to one of our health experts. They are always ready to explore new opportunities how we can leverage the power of technology to provide better health outcomes for all, together.