Greenlight Guru, a medical device quality management software (MDQMS) platform, has teamed up with Nelson Labs, a 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 its 13 global laboratory facilities. Together, the alliance offers quality management, biocompatibility testing and advisory services for medical device companies looking to mitigate risk and scale globally.
Through this strategic alliance, medical device companies gain access to Greenlight Guru’s modern, cloud-based MDQMS platform bundled with Nelson Labs 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 organisations aim to streamline the development process by pairing Greenlight Guru’s purpose-built quality management system alongside Nelson Labs exceptional advisory services.
David DeRam, CEO of Greenlight Guru, said: “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. 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.”
The joint offerings aims to help organisations:
- 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.
Todd Sierer, VP of sales and marketing at Nelson Labs, said: “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 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.”
