- Why Us
Ensure compliance from the start without lifting a finger. Your software comes aligned with 21 CFR Part 820, ISO 14971:2019, ISO 13485:2016, and FDA requirements.
Enhance team collaboration, break down information silos, and maintain a single source of truth. By reducing risk of noncompliance, your device can stay on the market longer.
Create a culture of quality from idea, to development, to post-market surveillance under one connected system.
Spend less time digging through spreadsheets and binders with every auditor request. With one interconnected, living database, you can get through audits with fewer issues in just a few clicks.
Give your team the tools they need to enable a culture of quality: compliant, yet flexible workflows for CAPAs, customer feedback, and audits.
Get over 70 audit-tested and customizable templates. Streamline system set-up, ensure compliance, and follow industry best practices from the start.
"Greenlight Guru was instrumental in implementing our quality system. With them, we can bring safer, higher-quality medical devices to success while maintaining a quality culture ...
“Purchasing Greenlight Guru was the best decision for our needs. Their easy-to-use eQMS, SOP Templates, and expert Guru guidance were key to us being able to successfully navigate ...