--- 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.) 5/14/2024 "Greenlight Guru is a great tool for SAMD company" 4.5/5 What do you like best about Greenlight Guru Quality Management System? GG has been a great tool that is geared towards serving our specific needs. Since it is focused on serving our company it is easier to use and can focus on features that matter to us most. The service is consistently improving and once you are used to workflow it is easy to use as the interface is consistent across modules. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? If you are new to eQMS it can be intimidating (not GGs fault), but it can take some time to understand the workflow of some tasks. Intially, I had a hard time with Change Orders and getting all of my changes to documents done. To their credit though through training I now understand, and don't have any issues doing those tasks. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Greenlight is managing our Quality system documentation and provides some guardrails to what we need that are specific to our industry. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite SC Seth C. Enterprise (\> 1000 emp.) 2/15/2024 "eQMS Usage Review" 4/5 What do you like best about Greenlight Guru Quality Management System? I really enjoy the simple user interface that the team at Greenlight has provided its customers/users. I think it is rather intuitive and easy for individuals/teams to be able to use the QMS. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? I don't have a lot of complaints really. I know that there are several features that could be implemented to enhance the potential of the system and eventually if those would be implemented then it would only make Greenlight more enjoyable 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? Greenlight Guru has been able to streamline a lot of our quality processes that we use at our organization. From virtually providing no limit as to the number of SOPs we can implement our organization due to a reduction of manual labor to just being able to have a "one source of truth" for everything...Greenlight has definitely allowed us to have more visibility on processes and more control on our data. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Aaron G.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Aaron G.") AG Aaron G. Consulting Medical Device Design Engineering Manager Small-Business (50 or fewer emp.) 11/22/2021 "Holistic Online QMS System for Medical Device Development" 5/5 What do you like best about Greenlight Guru Quality Management System? Online 24 hour access and quick help from the development team through chat and email. It's relatively easy to upload documents and create and edit the design matrix and risk matrix for our projects. Training is much improved over the previous year. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Training topics are sometimes difficult to find through keyword search. Support for previous risk matrix has ended and video training for old risk matrix is still there, so old video training keep showing up even though it is no longer relevant. Review collected by and hosted on G2.com. Recommendations to others considering Greenlight Guru Quality Management System: Our company is more of an edge-case for Greenlight Guru (GG), as we are a Consulting Product Developer. So it takes a bit more customization of procedures and processes to tailor the system to our needs. That being said, we are able to tailer the QMS to our needs, handling small clients with fast-developing projects, needing flexibility and ease-of use and low-touch, as well as highly complex years-long development projects with billion-dollar clients having established QMS systems of their own. We are pleased with the solution and would choose GG again. Throughout our partnership, GG has been evolving the product and adding capability, while increasing the ease-of-use. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? We use Greenlight as our QMS, run training events, and perform documentation management usingt this tool. Review collected by and hosted on G2.com. Show More 2/8/2024 Current UserValidated ReviewerSource: Organic ![Maxime R.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Maxime R.") MR Maxime R. Director, Regulatory Affairs, Quality Assurance and Clinical Affairs Small-Business (50 or fewer emp.) 11/16/2021 "How to Make Quality Assurance Simple" 5/5 What do you like best about Greenlight Guru Quality Management System? Create their fully traceable Design Control Matrix connected to Risk Management Make Changes efficiently and with full traceability Conduct Design Reviews and automatically generate their DHF Collaborate with partners and SMEs on document design control items Effectively conduct internal and supplier audits to discover root causes and implement required changes The product workspace is great to manage the BoM Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? We really need folders to manage documents. Right now there are no options to have multiple levels of folders. The options in a drop-down list are sometimes limited. We should be able to add our own items to some lists (like we can do for tags). I would like to have a space to manage recurring quality events (supplier evaluation, tool calibrations, etc.) No e-DMR, no e-DHR Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? The documents are way easier to control on Greenlight Guru and we have peace of mind regarding the management of the revision updates. The training management is also way easier. Review collected by and hosted on G2.com. Show More 2/8/2024 Current UserValidated ReviewerSource: Organic BG Bryan G. Tissue Recovery Technician Small-Business (50 or fewer emp.) 8/21/2024 "Simplifying training modules" 4/5 What do you like best about Greenlight Guru Quality Management System? The layout of what training have been completed and also the updated training yet to be completed. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Sometimes the system logs me out after only about five minutes and sometimes the verification process can be cumbersome Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Training updates are more streamlined and it is allowing more time for my job Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Marc M.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Marc M.") MM Marc M. Targeting Program Management, Project Plans, Lifecycle Management, Strategic Plannning Small-Business (50 or fewer emp.) 5/19/2024 "Greenlight Guru experiences with Start-ups" 5/5 What do you like best about Greenlight Guru Quality Management System? I like the templates which enable small companies to get a QMS system in place quickly. Also financial alternatives for smaller companies Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Not all documents are in a format that are easy to put into a format that is easy for sharing or submitting to regulatory authorities Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? I have spoken with quality consultants who like to see start-ups working in a compliant manner from the beginning and not have to stop and revise multiple documents when they decide to develop their QMS. These consultants like myself have found GG to work well for medical device companies. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Verified User in Education Management](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Education Management") AE Verified User in Education Management Mid-Market (51-1000 emp.) 8/21/2024 "Ease of Use is a great selling point" 3.5/5 What do you like best about Greenlight Guru Quality Management System? GG is an easy system for a person to set-up especially if they have limited knowledge of systems. Customer support is excellent and team is responsive to adding and changing features. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Cost is a bit prohibative for smaller teams and tiered pricing would be good to consider but understand there has to be value and return to consider. Seeing some turnover in staff that may be a little troubling but realistic for roles. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? GG allows for us to have a highly visable user friendly QMS Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Linet A.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Linet A.") LA Linet A. Quality Manager Small-Business (50 or fewer emp.) 8/21/2024 "Quality Manager of Contra Healthcare Solutions , previously was a Quality Auditor for TUV SUD" 2.5/5 What do you like best about Greenlight Guru Quality Management System? The projects module has a very good interface and links the necessary documents. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? It is not possible to keep track of the revision of my products and components since the system assigns it automatically, the revisions do not always coincide. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Good documentation and training modules and controls Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite RG Ryan G. Small-Business (50 or fewer emp.) 3/4/2024 "Implementation of GG" 4.5/5 What do you like best about Greenlight Guru Quality Management System? Flexable system for creating a QMS that allows functions to either occur within GG or outside of it when you haven't pruchased all the modules. It is very helpful that GG provides the SOPs, WIs and Forms to assist with the implementation and within the documents it has notes for when company specific details need to be added. Chat feature is extremely helpful and the Guru's are very quick to provide answers / work arounds for each organizational needs. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? The only drawback that I have encountered is the ability to correct typographical / formatting changes without having to go through the full release process and iterate the version. Subversioning with limited approval process requirements for these types of changes would be helpful. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Creating a complinat QMS. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite KS Kinga S. Mid-Market (51-1000 emp.) 5/22/2024 "Great eQMS - user friendly and all in one place" 5/5 What do you like best about Greenlight Guru Quality Management System? Greenlight Guru is a great eQMS system. All in one place. Easy to implement, easy to use. Great customer Support - if there is some query - it is solved really quick. At any point you can use learning academy, which include articles and videos on how to use system. System is updated frequenly with new features, which is really great to see. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? There is nothing what I dislike in Greenlight Guru Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Training space in Greenlight Guru solved our issues, from paper based to fully automated. 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) ![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(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);)