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Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster

January 6, 2021



Greenlight Guru, the med-tech industry’s leading medical device quality management software (MDQMS) platform, has teamed up with Nelson Labs, an industry-leading global provider of microbiology and analytical chemistry testing for MedTech and pharmaceutical companies. Nelson Labs offers more than 800 rigorous tests while employing more than 500 scientists in their 13 state-of-the-art global laboratory facilities. Together, the alliance offers world-class quality management, biocompatibility testing and expert advisory services for medical device companies looking to mitigate risk and scale globally.

Through this strategic alliance between two of the industry’s most trusted brands, medical device companies gain access to Greenlight Guru’s modern, cloud-based MDQMS platform bundled with Nelson Labs expert advisory services package to guide manufacturers with Biological Evaluation Planning & 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 exceptional advisory services.

“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. “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.”

Furthermore, the joint offerings will 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 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,’ said Todd Sierer, VP of Sales and Marketing at Nelson Labs.” 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.”

This announcement comes on the heels of significant enhancements to Greenlight Guru’s MDQMS with its recent launch of Quality Event Automation and Visualize, redefining the way medical device manufacturers approach closed-loop traceability. With the launch of Visualize, Greenlight Guru continues its mission to help medical device companies move beyond baseline compliance and achieve True Quality. The company is also celebrating two consecutive years as a G2 Crowd market leader in the quality management software category.

For more information about this pivotal industry alliance, please visit https://www.greenlight.guru/nelson-labs-alliance.


About Greenlight Guru
Greenlight Guru is the only quality management software platform designed specifically for medical device companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance, and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, and more. Greenlight Guru’s platform is used by thousands of users across the globe to push beyond baseline compliance and achieve True Quality for their medical devices. For more information, visit http://www.greenlight.guru.

About Nelson Labs
Nelson Labs®, a Sotera Health company, is an industry-leading, global provider of laboratory testing and expert advisory services. We perform over 800 rigorous microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. We know that every test matters and requires solutions to complex problems to improve patient outcomes and minimize client risk. Learn more about Nelson Labs at https://www.nelsonlabs.com/.


Media Contact
Kate Johnson
[email protected]
(317) 806-1900