Medical device quality management software developer Greenlight Guru announced earlier this week that it entered into a collaboration with Nelson Labs.
Indianapolis-based Greenlight Guru said in a news release that the strategic partnership allows Nelson Labs to gain access to its cloud-based MDQMS platform while using the testing laboratory’s advisory services package to guide manufacturers with biological evaluation planning and regulatory compliance.
Among the joint offerings provided by the partnership are streamlined and automated product development, documentation and quality processes, as well as an understanding of closed-loop quality system traceability, Greenlight Guru said.
Additionally, the collaboration is seeking to reveal harms linked to design outputs or testing and validation documentation while limiting time and cost, and developing a gap analysis of new testing requirements for bringing devices into compliance with updated ISO guidelines and EU MDR.
“Our strategic alliance with Nelson Labs allows our customers to gain expert biocompatibility advice for their product design early on,” Greenlight Guru CEO David DeRam said in the release. “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.”
