Product Overview
Unlock efficiency with the leading cloud-based QMS software designed to improve speed and quality while lowering risk and cost. Chasing signatures, scrambling through audits, and manually building traceability isn’t why you got into this business. With efficiency designed for MedTech, you can focus on what’s important: improving more lives, faster.
Your QMS software is optimized for the unique challenges and strict requirements of MedTech. Connect your people, processes, and data under one single source of truth.
- 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.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
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.
- Your documents should increase efficiency, not slow you down. Seamlessly review, approve, update, and link documents all in the cloud. All with a click.
- The most advanced design controls functionality for MedTech. Intuitively integrate risk while you design, manage traceability, and maintain a living history file.
- Connect your quality and product development teams to streamline collaboration, increase efficiency, and reduce risk across your product lifecycle
About the company
In 2006, Jon Speer, a medical device engineer turned consultant, had the initial idea for Greenlight Guru, when he made a simple observation: paper-based quality management systems (QMS) are painful, risky, and inefficient. At the time, commercial QMS solutions had been available for nearly two decades, but only 30% of MedTech companies were actually using them. This observation led Jon and his co-founder, David DeRam, to develop Greenlight Guru. Today, with our powerful, intuitive solution, MedTech companies across the world can bring higher quality, life-changing products to market faster, more efficiently, and with less risk.
