Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster
Greenlight Guru has teamed up with Nelson Labs, one of the industry’s leading global provider of microbiology and analytical chemistry testing for MedTech and pharmaceutical companies.
This strategic alliance provides medical device companies with access to Greenlight Guru’s modern, cloud-based MDQMS platform bundled with a Nelson Labs Expert Advisory Services package to guide manufacturers with Biological Evaluation Planning & Regulatory Compliance Consulting.
Customers will benefit from seamlessly sharing device information from Greenlight Guru to help Nelson Labs perform their risk evaluation, thus accelerating validation and verification for new products.
Additionally, the joint offerings will allow organizations to:
- Streamline product development, documentation, and quality processes in alignment with major industry standards and regulations
- Limit the time and cost associated with developing a Biological Evaluation Plan
- Mitigate potential risks that could delay market access and production timeline
- Understand and achieve closed-loop quality system traceability
- Reveal any harms linked to design outputs or testing and validation documentation
- 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