Greenlight Guru and Nelson Labs have formed an alliance offering quality management, biocompatibility testing, and expert advisory services for medical device companies looking to mitigate risk and scale globally. Greenlight Guru offers medical device quality management software (MDQMS) platform, while Nelson Labs provides microbiology and analytical chemistry testing for medtech and pharmaceutical companies. Nelson Labs offers more than 800 rigorous tests and employs more than 500 scientists in their 13 state-of-the-art global laboratory facilities.
Through this alliance, medical device companies gain access to Greenlight Guru’s cloud-based MDQMS platform bundled with Nelson Labs expert advisory services package to guide manufacturers with biological evaluation planning and regulatory compliance consulting. Greenlight Guru’s MDQMS platform enables closed-loop quality traceability for real-time audit readiness while accelerating product development activities. The two organizations aim to streamline the development process by pairing Greenlight Guru’s purpose-built quality management system alongside Nelson Labs advisory services, they reported in a news release.
“Our strategic alliance with Nelson Labs allows our customers to gain expert biocompatibility advice for their product design early on. This helps them to mitigate risk by eliminating toxic materials and ensure success by bringing their devices into compliance and to the market faster,” said David DeRam, CEO of Greenlight Guru, in the release. “We continually work to increase value for our customers and adding partners like Nelson Labs to our global ecosystem of industry relationships is a critical component in that initiative.”
Adds Todd Sierer, VP of sales and marketing at Nelson Labs: “This alliance provides medical device developers the ability to seamlessly transfer information from their Greenlight Guru MDQMS to help form their risk evaluation, thus accelerating their validation process for new products. Nelson Labs Advisory Services team can leverage this consolidated information stream to provide holistic support as Greenlight Guru customers transition from planning to product development and testing.”
The alliance aims to help organizations:
- --Streamline and automate product development, documentation, and quality processes in alignment with guidelines from major industry standards and regulations.
- --Understand and achieve closed-loop quality system traceability.
- --Reveal any harms linked to design outputs or testing and validation documentation.
- --Limit the time and cost associated with developing a Biological Evaluation Plan.
- --Mitigate potential risks that could delay market access and production timeline.
- --Develop a gap analysis of new testing requirements needed to help bring their devices into compliance with the updated ISO guidelines and the new MDR.
This announcement follows Greenlight Guru’s recent launch of Quality Event Automation and Visualize, developed to help medical device manufacturers approach closed-loop traceability.