--- 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") EM Verified User in Medical Devices Small-Business (50 or fewer emp.) 2/29/2024 "The training has been good." 4/5 What do you like best about Greenlight Guru Quality Management System? The system allows for easy approval of documents. When we have had issues, many of them have been added to the updates Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Once the document is loaded for approval, even simple typos can not be corrected without a revision being needed. There is no way to provide a red-lined document for review. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? We are starting to move our documents from paper to electronic. I am hoping that we will be able to make sure that documents can be cross referenced easily so that we don't miss other documents that should be changed when we change others Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Mila H.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Mila H.") MH Mila H. Small-Business (50 or fewer emp.) 2/15/2024 "positive and quick to learn" 4/5 What do you like best about Greenlight Guru Quality Management System? Risk management and CO management, also customers feedback workspaces, pretty helpful Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? BOM or Product management workspace is not really flexible. For the complex device its hard to manage BOm in GG, any small change in device required comlete changes in BOM, which with our System is totally waste of time. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? easy management of docs, and different aspects of QMS throught its workspaces Review collected by and hosted on G2.com. Show More Current UserValidated 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.) 2/23/2024 "Intuitive and ready to use" 5/5 What do you like best about Greenlight Guru Quality Management System? The onboarding experience during implementation has been well developed by the implementation team. They provide plenty of resources both as part of the implementation project as well as in the Academy; a great value especially for a small company with a young QMS. Customer support team is responsive and always willing to find a solution for any issue. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Some of the user interface is not as intuitive as it could be, i.e. menu items in obscure locations and icons without hover-on text Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Quality system reporting: CAPA, NCR, Audit which was previously paper-based. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Jessica H.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Jessica H.") JH Jessica H. Small-Business (50 or fewer emp.) 3/4/2024 "eQMS made easy" 4.5/5 What do you like best about Greenlight Guru Quality Management System? It's just so simple and easy with so much support along the way Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? It took me a little while to get used to using the software but once I had it's very easy to use Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Making it easy to have an organised QMS all stored in one place Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Marco G.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Marco G.") MG Marco G. Chief Technology Officer Small-Business (50 or fewer emp.) 3/4/2024 "Simple and Easy" 5/5 What do you like best about Greenlight Guru Quality Management System? It's really intuitive to use, and all of the necessary templates were provided making the QMS building easy. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? I am sorry, I can't think of any negative feedback. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? It allows us to consolidate our Quality files into a single cloud based system. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite MD Matthew D. Small-Business (50 or fewer emp.) 7/25/2023 "Reliable and Scalable document control tailored for the US MedTech industry" 4/5 What do you like best about Greenlight Guru Quality Management System? 1. Updates and major improvements to the system as their customer demand focuses on not just 13485 but also MDR. 2. The community of users, gurus, vendors/partners, and special events that bring value beyond the cost of the software. 3. End users appreciate being able to see related procedures, work instruction in a few clicks or as a saved view saving valuable time having employees search through files (either paper! or digital) Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? 1. The learning environment is riddled with content behind a pay-for-content wall. Additinonally there is no clear way to access or understand what is being offered. Some of the content is available as blog posts if you interact with their landing pages. It's just very disorganized. 2. Contractually your limited to number of users. Both for full users and lite users. You pay for both, but after time you realize that the only lite users should probably be external auditors. 3. This SASS does not offer a user forum which means relying on GLG or a consultant for simple answers. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? GLG ecosystem had everything we needed to convert from a paper based system with design excluded to a modern QMS that stays updated. In my world, Quality and Regulatory have had a spotlight on them since we purchased GLG. When executed well, the transition to GLG is likely to show management that your previous QMS is missing more than you think. 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-8353834/official_response/edit) Thanks for your feedback, Matthew! We love to see your interest in our content - but we know there is a LOT! Anything product-related is free to our customers in Greenlight Guru Academy. If you are having trouble finding where to start, your Customer Success Manager would be happy to suggest some of the most relevant courses to you and your desired outcomes. Additionally, our Help Center provides more helpful content. This can be found in the dropdown menu in the upper right corner of your QMS. Current UserValidated ReviewerSource: Organic TB Tara B. Small-Business (50 or fewer emp.) 2/14/2024 "SVP, Regulatory Affairs" 5/5 What do you like best about Greenlight Guru Quality Management System? Compliance with FDA Medical Device Regulations, User Friendly, Intuitive, Contains all features of an eQMS to allow for one system. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? No quizzes within the training environment. No links to Azure Dev Ops. No ability to externally export documents for customers to retrieve without a user license. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? intuitive solution Review collected by and hosted on G2.com. Show More 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 Mid-Market (51-1000 emp.) 5/14/2024 "I have had a positive experience with Green Light Guru" 3/5 What do you like best about Greenlight Guru Quality Management System? Once you get the hang of it, it is easy to navigate documents Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Trying to search for a specific document by our Site. (BRI) Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? With a click of a few buttons we can quickly access our released controlled documents Review collected by and hosted on G2.com. Show More Current UserValidated 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 Mid-Market (51-1000 emp.) 3/5/2024 "I think the system is stright forward but do not like the automation feature." 3.5/5 What do you like best about Greenlight Guru Quality Management System? I like how the EQMS is set up for easy use. I love that the support team turn around time is fast. Implementation was very easy. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? The automation feature. I find it useful in some cases and not in others. I Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? A huge transition for was having a system to create and close CAPAs. I love the CAPA workflow in Greenlight Guru and our staff has said nothing but great things about it. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite RC Robert C. Small-Business (50 or fewer emp.) 2/14/2024 "eQMS Toolbox" 3.5/5 What do you like best about Greenlight Guru Quality Management System? The user interface is a lot easier to use then other software like this on the market. A Good eQMS Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Found out lately that there is not a way to build folders within the system. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? DOCUMENTS ARE NO LONGER PAPER!!! Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller 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) 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) ![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) [ 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(463) [ 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 [Which vendor provides the most advanced data quality management tools?](https://www.g2.com/discussions/which-vendor-provides-the-most-advanced-data-quality-management-tools)[Which museum management solutions do teams actually adopt and continue using long-term?](https://www.g2.com/discussions/which-museum-management-solutions-do-teams-actually-adopt-and-continue-using-long-term)[Best payroll software for small business](https://www.g2.com/discussions/best-payroll-software-for-small-business) [Ecwid vs PrestaShop for a small online store: which is easier to set up and grow with?](https://www.g2.com/discussions/ecwid-vs-prestashop-for-a-small-online-store-which-is-easier-to-set-up-and-grow-with)[What's the most recommended customer success platform for SaaS companies](https://www.g2.com/discussions/what-s-the-most-recommended-customer-success-platform-for-saas-companies)[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);)