--- title: Greenlight Guru Quality Management System Reviews meta\_title: 'Greenlight Guru Quality Management System Reviews 2026: Details, Pricing, & Features | G2' meta\_description: Filter 411 reviews by the users' company size, role or industry to find out how Greenlight Guru Quality Management System works for a business like yours. aggregate\_rating: rating\_value: 4.5 review\_count: 411 scale: '5' date\_modified: '2026-08-09' parent\_category: name: Environmental, Quality and Safety Management url: https://www.g2.com/categories/environmental-quality-and-safety-management --- # Greenlight Guru Quality Management System Reviews & Product Details Visit Website Greenlight Guru is the #1 quality management system built exclusively for medical device companies. Not life sciences. Not pharma with a medtech configuration layer. Because we built exclusively for medical devices, ISO 13485, ISO 14971, and FDA QMSR aren't frameworks you configure after the fact. They're the foundation. Most quality teams manage compliance across systems that were never designed to talk to each other. A document control tool here, a spreadsheet for CAPAs there, a separate process for change control. In a regulated environment, that gap doesn't stay invisible, it shows up during audits. Greenlight Guru gives Quality and Product teams a single connected system where document control, training, CAPA, nonconformance, change control, supplier management, risk management, and design controls work together. When a change happens, it flows through the workflow. Meaning limited manual handoffs, and nothing falling through the cracks between teams. For Quality and Regulatory Affairs professionals, that means audit-ready workflows with automated routing, electronic signatures, and complete audit trails built in, including end-to-end traceability across design controls. No more chasing approvals or manually tracking compliance status. Teams that run on Greenlight Guru are 3.5x less likely to receive a major audit finding. For R&D and product teams, it means staying in the tools they already use, with changes automatically syncing to design controls so documentation builds itself as you work, not after the fact as a separate project. Greenlight Guru AI handles the repetitive work that slows teams down, and it was built with 15 years of medtech context behind it, not bolted on from a general-purpose model. AI-powered search finds answers across your QMS instantly. Chat analyzes system data to surface insights. Auto-generated summaries give immediate context on documents, suppliers, and quality events. For product teams, verifiability checks catch vague requirements before they become audit findings, suggested links close traceability gaps automatically, and AI brainstorming gets engineers moving faster. For quality teams, AI generates training quizzes and drafts change order summaries, so your team spends less time writing and more time on the work that actually requires their expertise. The platform is validated out of the box and aligned to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR Part 11. Implementation is measured in weeks, not the quarters-long projects that come with legacy enterprise platforms. Backed by 80+ audit-tested, customizable templates and a team of experts who know medtech inside and out. You're not managing a separate validation project before you can go live. For 15 years and across more than 1,000 device companies worldwide, Greenlight Guru has been the QMS medical device teams trust to pass audits, bring products to market, and stay on the market longer. * * * Product Website Greenlight Guru Quality Management System Seller [Greenlight Guru](https://www.g2.com/sellers/greenlight-guru) Discussions [Greenlight Guru Quality Management System Community](https://www.g2.com/products/greenlight-guru-quality-management-system/discuss) Languages Supported English Solution Type Best-of-Breed Show More ## Value at a Glance Averages based on real user reviews. ### Time to Implement 3 months [ View More Pricing Information ](https://www.g2.com/products/greenlight-guru-quality-management-system/pricing) ## Greenlight Guru Quality Management System Integrations (4) What do users say about integrations? Verified by Greenlight Guru Quality Management System [ ![Product Avatar Image](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Product Avatar Image") GitHub ](https://www.g2.com/products/github/reviews)[ ![Product Avatar Image](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Product Avatar Image") Google ](https://www.g2.com/products/google-google/reviews)[ ![Product Avatar Image](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Product Avatar Image") Jira ](https://www.g2.com/products/jira/reviews)[ ![Product Avatar Image](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Product Avatar Image") Microsoft 365 ](https://www.g2.com/products/microsoft365/reviews) Show More ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices") UM Verified User in Medical Devices Small-Business (50 or fewer emp.) 2/14/2024 "Great eQMS" 4.5/5 What do you like best about Greenlight Guru Quality Management System? Several things I like about Greenlight Guru are ease of implementation, ease of use, and customer support. I also like the Academy where you can educate youself on the features of eQMS and the live webinars where you can get all of your questions answered. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Some of the moduleas are too cumbersome and complicated for the small size companies. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Going digital was a huge move for our complany from being paper-based. No more wasted paper! Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Verified User in Computer Software](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Computer Software") AC Verified User in Computer Software Mid-Market (51-1000 emp.) 11/10/2023 "Good functionality for QMS - Medical Device use!" 4.5/5 What do you like best about Greenlight Guru Quality Management System? Puts the major components of QMS into one software location that makes it easier to locate documents and actions taken within the CAPA and Audit functions. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? The software needs more automation built in such as when you deactivate an employee, the software should automatically remove the deactivated employee from the training modules that are in progress. Overall though this remains a solid software system and GG is making upgrades continually to improve the software based on customer suggestions and recommendations. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Revisions and changes to procedures are easily captured within GG which solves the issues of errors and manual input into a revision history. Procedures as well as training assignments are available with a single login to all employees. Review collected by and hosted on G2.com. Show More Response from Kaitlyn Sawin of Greenlight Guru Quality... [Editedit](https://www.g2.com/survey_responses/greenlight-guru-quality-management-system-review-8854122/official_response/edit) Thanks for your review! Our November 2023 release introduced some automation for the exact use case you state. Onboarding and offboarding users just got easier! We hope you enjoy the new functionality. Current UserValidated ReviewerIncentivizedSource: G2 Gives Campaign AA Anna A. Mid-Market (51-1000 emp.) 8/2/2023 "Very user friendly and always improving" 5/5 What do you like best about Greenlight Guru Quality Management System? Greenlgiht Guru has been implemented as our eQMS and has made document managment, review and approval very efficient. The software is user friendly and most of our staff are able to use it intuitively. Greenlight Guru are very focused on making improvements and they have taken on much of our feedback and acted on it. In my opinion, the best features are the ability to link anything (documents, training, Audits, CAPA, NCs) to one another. flexible document management with customisable values and attributes, and the overall UI. Greenlight Guru has really made Audits a much smoother process. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Areas for improvement for greenlight would be management of tasks, document review cycles, and more flexibility for the in the Change workspace i.e. reviewers not needing to review every document and evaluation in a CO. Greenlight Guru have been proactive in seeking feedback and they have been great at providing updates on the impvorements they are working on. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Greenlight has removed the need for almost all our paper based documents and records management. We use it to issue and record all of our training across the company Review collected by and hosted on G2.com. Show More Validated ReviewerIncentivizedSource: Seller invite ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices") AM Verified User in Medical Devices Small-Business (50 or fewer emp.) 2/16/2024 "Greenlight Guru has made establishing a QMS almost too easy" 5/5 What do you like best about Greenlight Guru Quality Management System? The eQMS is super easy to use, and very interactive Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? I haven't any negative experinces using it yet Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Everything we need to get a medical device to market is all located in one space Review collected by and hosted on G2.com. Show More 3/9/2024 Current UserValidated ReviewerIncentivizedSource: Seller invite ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices") UM Verified User in Medical Devices Small-Business (50 or fewer emp.) 3/4/2024 "Using Greenlight Guru for small medical device business." 4/5 What do you like best about Greenlight Guru Quality Management System? It's a very simple and organized QMS system once you figure out all the details. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? It can be a lot to learn when first starting. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? It is simplifying our QMS processes. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Barry M.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Barry M.") BM Barry M. Small-Business (50 or fewer emp.) 7/28/2023 "My Assessment of Greenlight Guru Electronic Quality Management Software" 5/5 What do you like best about Greenlight Guru Quality Management System? The quality of the software, its user friendliness, the knowledge of the Gurus with regards to the software and regulatory requirements, the onboarding programs Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? I can't think of any downside of anything I dislike about it Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? I think this is fabulous software. The Gurus are extremely knowledgeable about both the software and the medical device industry regulatory requirements and the software. The have an excellent onboarding program and the software is very user friendly. It provides the templates for all of the procedures a company require to meet 21CFR 820. ISO 13485/2016 and MDR 2017. It would be an enormous and costly task requiring a lot of resources for small start like us to understand the regulations well enough to create all the documents and procedures to meet to meet these regulatory task. Review collected by and hosted on G2.com. Show More 7/29/2024 Validated ReviewerIncentivizedSource: Seller invite ![Tara B.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Tara B.") TB Tara B. Vice President of Regulatory Affairs and Compliance Small-Business (50 or fewer emp.) 8/4/2023 "FDA compliant eQMS product that is user friendly and intuitive provided by outstanding Partner." 5/5 What do you like best about Greenlight Guru Quality Management System? Greenlight Guru is built specifically for medical device manufacturers and was built to comply with the applicable regulations for meddev. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Greenlight Guru did not have an open API at the time of our implementation, but this is something they are working on. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Greenlight Guru has provided us with an eQMS that will house all of our quality systems into one system all within a system that complies with FDA regulations. Greenlight Guru offers a user friendly, intuitive eQMS providing internal customer statisfaction in addition to regulatory compliance. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Stacy M.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Stacy M.") SM Stacy M. Vice President of Quality Mid-Market (51-1000 emp.) 11/17/2021 "Greenlight Guru makes Quality Management Easy" 4.5/5 What do you like best about Greenlight Guru Quality Management System? Greenlight Guru makes managing Quality operations easy by being a singular platform for: Documents Training NonConformances Audits Product Development Being able to link items together allows for easy visibility to the interdependencies. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? The one thing I would improve is the user access levels. Users can only get lite user or full user access. Some individuals in the company need to have more ability than a lite user in order to upload documents, open change orders, initiate complaints and/or non-conformances, while some users only need the ability to complete training and view documents. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Greenlight Guru is continuously improving upon the functionalities within the platform such as training notifications, Risk Management and flexible documents. This has eased the performance of daily tasks and allowed for smoother completion of tasks. Review collected by and hosted on G2.com. Show More 5/12/2023 Current UserValidated ReviewerIncentivizedSource: Seller invite ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices") UM Verified User in Medical Devices Small-Business (50 or fewer emp.) 2/21/2022 "Positive experience with GG software and services" 4.5/5 What do you like best about Greenlight Guru Quality Management System? It helps and support the company to do the right thing in relation to standards and regulations. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Some functions for example searching for documents are not very user friendly. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Electronic signatures, document review and approval, version handling, templates for SOPs and WIs. We have quickly succeded to obtain ISO 13485 certification. The NB was very impressed with GG and the way we used it for our QMS. Review collected by and hosted on G2.com. Show More 11/20/2023 Current UserValidated ReviewerSource: Organic KH Katie H. Small-Business (50 or fewer emp.) 4/5/2023 "Pricing model worse than salesforce" 1/5 What do you like best about Greenlight Guru Quality Management System? It does it's job with document & risk management. The UI is fairly easy to use; change orders, flow charts and audits easy enough to use. I wish search function worked better. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Something they don't tell you: You can't adjust your number of users. Oh you can go up, but you can never go back down in # of licenses. I'm stuck with too many licenses for the next 4.5 years. I only wanted to remove 3 licenses, but they refuse. I've never heard of a SAAS that doesn't let you edit your number of users. It's shady. They hide it from you: it's not in the contract and not standard practice and you don't find out about it until it's too late. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? We're using GG for our medical device startup as a QMS for FDA & ISO compliance Review collected by and hosted on G2.com. Show More Response from Kaitlyn Sawin of Greenlight Guru Quality... [Editedit](https://www.g2.com/survey_responses/greenlight-guru-quality-management-system-review-7902874/official_response/edit) Thanks for providing this feedback, Katie! We apologize for this experience, however, we have since been able to rectify the situation with your organization's CEO. If your experience with Greenlight Guru has improved, we would sincerely appreciate you updating your review to more adequately reflect how our software has helped your organization. Current UserValidated ReviewerIncentivizedSource: G2 invite ## Questions about Greenlight Guru Quality Management System? Ask real users or explore answers from the community Get practical answers, real workflows, and honest pros and cons from the G2 community or share your insights. [ Ask about Greenlight Guru Quality Management System ](https://www.g2.com/products/greenlight-guru-quality-management-system/discussions/new) ![Verified User](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User") G2 Verified User • Last activity over 6 years ago Can my medical device company benefit from using Greenlight Guru’s software if we are based outside the US or intend to sell our devices into international markets? 2 Upvotes 1 [ Join the conversation ](https://www.g2.com/discussions/markets-served) JK Jeroen Kruijer • Last activity over 4 years ago When do you think a planning tool/Calender can be incorporated in Greenlight Guru? 2 Upvotes 1 [ Join the conversation ](https://www.g2.com/discussions/when-do-you-think-a-planning-tool-calender-can-be-incorporated-in-greenlight-guru) [ View all Discussions ](https://www.g2.com/products/greenlight-guru-quality-management-system/discuss) ## Pricing Insights Averages based on real user reviews. ### Time to Implement 3 months ### Return on Investment 22 months ### Average Discount 12% [ View More Pricing Information ](https://www.g2.com/products/greenlight-guru-quality-management-system/pricing) Greenlight Guru Quality Management System Comparisons ![Product Avatar Image](https://images.g2crowd.com/uploads/product/image/small_square/small_square_239fdb020d69919db5553a9bf0b0e605/qualio.jpg "Product Avatar Image") Qualio 4.4/5(781) [ Compare Now ](https://www.g2.com/compare/greenlight-guru-quality-management-system-vs-qualio) ![Product Avatar Image](https://images.g2crowd.com/uploads/product/image/small_square/small_square_952e9aa4df0af1b0706297e2afcb725f/mastercontrol-quality-management-system.png "Product Avatar Image") MasterControl 4.3/5(528) [ Compare Now ](https://www.g2.com/compare/greenlight-guru-quality-management-system-vs-mastercontrol-quality-management-system) ![Product Avatar Image](https://images.g2crowd.com/uploads/product/image/small_square/small_square_62ce07a97b655c6f93cfa06af1edb429/arena-plm-qms.png "Product Avatar Image") Arena PLM & QMS 4.2/5(464) [ Compare Now ](https://www.g2.com/compare/arena-plm-qms-vs-greenlight-guru-quality-management-system) ##### ##### Greenlight Guru Quality Management System Features Quality Management Design Controls Risk Management Quality System Real-time Collaboration Document Control Nonconformance Conformance Records CAPA Change Management Quality system Document Control Collaboration Analytics and Reports [ View More Features ](https://www.g2.com/products/greenlight-guru-quality-management-system/features) ## Top-Rated Alternatives [ ![Qualio](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Qualio") Qualio 4.4/5(781) ](https://www.g2.com/products/qualio/reviews) [ ![Octave Reliance (ETQ Reliance)](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Octave Reliance (ETQ Reliance)") Octave Reliance (ETQ Reliance) 4.3/5(624) ](https://www.g2.com/products/octave-reliance-etq-reliance/reviews) [ ![MasterControl Quality Management System](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "MasterControl Quality Management System") MasterControl Quality Management System 4.3/5(528) ](https://www.g2.com/products/mastercontrol-quality-management-system/reviews) [ View All Alternatives ](https://www.g2.com/products/greenlight-guru-quality-management-system/competitors/alternatives) ##### Categories on G2 [Quality Management (QMS)](https://www.g2.com/categories/quality-management-qms)[Medical QMS](https://www.g2.com/categories/medical-qms) ##### Explore More [Is KeyShot worth the licence cost for product visualization work?](https://www.g2.com/discussions/is-keyshot-worth-the-licence-cost-for-product-visualization-work)[What failover and high availability capabilities should teams evaluate in web server accelerator solutions?](https://www.g2.com/discussions/what-failover-and-high-availability-capabilities-should-teams-evaluate-in-web-server-accelerator-solutions)[Best Remote Desktop Software](https://www.g2.com/discussions/in-your-opinion-what-is-the-best-remote-desktop-software) [Best platforms for integrating PM with estimating tools](https://www.g2.com/discussions/best-platforms-for-integrating-pm-with-estimating-tools)[Which application release orchestration tools give an engineering team full audit trails and compliance reporting for releases so regulated industries can pass deployment audits?](https://www.g2.com/discussions/which-application-release-orchestration-tools-give-an-engineering-team-full-audit-trails-and-compliance-reporting-for-releases-so-regulated-industries-can-pass-deployment-audits)[Pros and Cons Details](https://www.g2.com/products/greenlight-guru-quality-management-system/reviews?qs=pros-and-cons) [Show MoreShow Less](javascript:void(0);)