EASILY ACCESS AND CONTROL DOCUMENTS.
DOCUMENT YOUR DESIGN CONTROLS WITH FULL TRACEABILITY.
GAIN NEW VISIBILITY AND MITIGATE RISK.
Essentials package and:
CREATE A CONNECTED QUALITY ECOSYSTEM.
STREAMLINE TEAM ACTIVITIES.
ACHIEVE COMPLIANCE AND STAY AUDIT READY.
Plus package and:
VISUALIZE YOUR QMS
ANALYZE & PREDICT IMPACT
ENHANCE YOUR TEAM WITH AN EXTENSION OF OURS.
Our seasoned medical device Guru's will ensure that you have what you need for your QMS implementation to run smoothly, while also providing clarity around the regulatory process and best practices for managing quality throughout your device's lifecycle.
DEDICATED QUALITY & REGULATORY EXPERT
GET STARTED WITH THE RIGHT DOCUMENTATION.
These audit-tested procedures, work instructions, and form will streamline the implementation of your quality management system and save you time during implementation and audits.
AUDIT-TESTED TEMPLATES FOR YOUR QMS
Our Customer Success team is here to do more than solve technical issues. At Greenlight Guru, we value fanatical support. That means our noteworthy Customer Success and Medical Device Guru teams on your side to ensure that you and your team are always supported and on track to achieve success. They are here to help your team implement, maintain, and extract full value from your QMS to further your business. Your outcomes shape our outcomes - when you succeed, so do we.
G2 Crowd provides real-time and unbiased user reviews to help you objectively assess what software is best for your business.
We searched for a digital solution to see if one was available after being told that only paper-based systems would satisfy FDA. We found Greenlight Guru and have been delighted with both the product and the service. Greenligh Guru gives us a digital QMS so that we can safely launch our first four products. We feel confident our system can withstand any FDA audits.
The DC and Risk matrices make Greenlight Guru a great software for medical device companies. The ability to link the design controls and risk elements together allow companies to develop safe and effective devices. The application also allows our teams to work together from different locations in order to accommodate everyone's schedules! The Greenlight Guru software keeps a log of all changes made in the system. This means each time a user views, edits, approves, rejects, etc. an input in the software, the data is captured and can be pulled for reference. This allows for traceability...
Read the Full Review
The software allows me to mitigate my regulatory and compliance risk, I have been able to implement a world class eQMS that rivals the largest companies in med device. Greenlight has the best in class support, it is both software and service.
Real time reviewing and publishing of quality documents. GUI of website makes it very easy to navigate without any hassle.
The support at Greenlight Guru has been incredible. There is live chat available and any question [is answered] in a matter of minutes! This extends beyond just how does system support. Greenlight Guru is able to answer questions related to ensuring that your system is compliant to the necessary standards required for medical devices.
Easy to upload, organize, and find documents