--- 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.) 5/26/2026 "Hard to Maintain Compliance for Medical Device Standards" 1/5 What do you like best about Greenlight Guru Quality Management System? The system is relatively simple and easy to learn. Email notifications are helpful. Suitable for small companies that are not looked at carefully by regulatory bodies. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? For a medical device company, Greenlight is difficult to maintain in a way that is compliant to standards and regulations. Specific issues: In Quality Processes, unable to route for approvals before final stage. Nonconformance, Customer Feedback and CAPA worflows do not follow industry standard. In Documents module, cannot add more than one file to an item. Unable to customize. The company has been non-responsive in attempts to provide feedback. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Maintains quality records effectively. Document control process is decent. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: G2 invite on behalf of seller ÅK Åsa K. Small-Business (50 or fewer emp.) 8/3/2023 "Very useful tool" 4.5/5 What do you like best about Greenlight Guru Quality Management System? Supplier and Training and Audit modules are efficient and useful for documenting all related documents in the same place. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Search functions are not very helpful and precise. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? GG is framing the work needed to be compliant to ISO 13485 and is providing updated SOP templates to help stay compliant. Review collected by and hosted on G2.com. Show More 6/10/2026 Current UserValidated ReviewerIncentivizedSource: Seller invite ![Anna N.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Anna N.") AN Anna N. Small-Business (50 or fewer emp.) 4/21/2026 "User-Friendly Dashboard with Powerful Document Control" 4.5/5 What do you like best about Greenlight Guru Quality Management System? I like that the Greenlight Guru Quality Management System is user-friendly with an easy dashboard. I also appreciate the visualization of the design matrix and risk assessment, plus the document comparison. It's great for reviewing documents before approving and conducting audits. The agility of the system stands out too. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? I find searching files and adding comments on the development sections challenging. It took a year to deploy because uploading past information and updating all our GPs to include Greenlight Guru were quite time-consuming. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? I use Greenlight Guru Quality Management System for document control, training, and design & development. It solves file accessibility, centralization of information, and history control. Review collected by and hosted on G2.com. Show More Validated ReviewerIncentivizedSource: G2 invite on behalf of seller ![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.) 4/21/2026 "Easy Linking of Changes, NCMs, and Audits Makes Quality History Clear" 5/5 What do you like best about Greenlight Guru Quality Management System? Linking changes, NCMs, and audits makes our quality history easy to follow . Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? It is another system to use outside our other ERP products. The price of Greenlight discourages me from trying to get all our staff accounts to view work instructions, so I end up using a separate system for that. But the medical product focus and easy linking outweighs that problem just enough. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Foremost I want good quality. Being able to track design decisions and build the right verifications for each change makes a difference. As a result, it makes audits smooth. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: G2 invite on behalf of seller VC Vikram C. Small-Business (50 or fewer emp.) 2/21/2023 "Very good and easy to use QMS system" 4/5 What do you like best about Greenlight Guru Quality Management System? Document management -Change management and new training Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? I think the audit function can be improved a bit. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Managing training is the best functionality which is benefiting us. Review collected by and hosted on G2.com. Show More 6/15/2026 Current UserValidated ReviewerIncentivizedSource: G2 invite on behalf of seller ![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.) 8/19/2022 "Greenlight Guru Review" 3/5 What do you like best about Greenlight Guru Quality Management System? Good support and they added suppliers section which helps with management but this is kept separate from our other business systems which rely on it as a separate database. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? same thing lack of integrated pFMEA, folders is still not out and still need our MRP/ERP separate for business operations Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Quick implementation of a QMS with excellent customer support. Very quick change request and document control system. Review collected by and hosted on G2.com. Show More 6/10/2026 Current UserValidated ReviewerIncentivizedSource: G2 invite on behalf of seller ![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.) 10/29/2025 "Best QMS for Medical Device Design Firms—Robust Features, Stellar Support, Minor Analytics Gaps" 4.5/5 What do you like best about Greenlight Guru Quality Management System? GG is the best eQMS for traditional medical device design and development (can't speak for software dev). We looked at many systems but would have had to keep our design matrices and risk in excel. The design workspace is build to ISO 13485 and allows you to link your design items to relevant documents and related risk items. You can document design reviews in software and print a simple design file. Risk is built to ISO 14971 and doesn't trap you into just FMEA. It incorporates harmonized IMDRF terms for hazards and harms and includes various regulatory codes, which is great for regulatory reporting. You can review and lock your risk analysis in a way that makes it easy for risk to stay a living "document". You can view documents in app, which is surprisingly not a feature for many systems and a must have for me. Attributes and tags make it easy to organize and find documents. Change management is flexible and allows you to route multiple documents at a time. Training is great, I can automate SOP training so nothing gets missed. The quality events could be improved but are workable and you can link audits to CAPAs to risk to documents which is great. Admin has got to be the easiest of any out of the box software and the support is world class. If you want a super custom system, this probably isn't for you. If you need a quick and straightforward implementation and are happy with a system built for ISO 13485 and ISO 14971 take a look! We were mostly implemented in 3 months and fully implemented by 5 with everyone trained! Almost all of the users find it intuitive to join, train, and sign off on change and documents. Users that use it for quality events, design, risk, and admin were able to feel comfortable very quickly. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Quality events are inflexible but are at least built to include CAPA requirements for med dev. Analytics is limited, but still can provide some valuable data. It would be great if there was an easier way to get signatures from external users (like suppliers) without inviting them into you system, but it's not hard to work around. Biggest complaint is pricing. It may not be competitive for many teams. It's annoying to pay for extra projects. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? We were completely paper-based, so signatures, training, document management were all very challenging and created many gaps in our system. Audit readiness is much less of a headache; we can quickly see the exact status of our employees' training and find documents quickly (we've been praised in our most recent audits for this). Collaboration is great. Anyone can access it from anywhere! All of our design files were out of date and matricies and risk were a mess. Is a huge improvement here. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: Organic ![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.) 8/26/2022 "Easy navigation and great customer service" 4.5/5 What do you like best about Greenlight Guru Quality Management System? It has a great interface and the features with the new upcoming AI is really helping Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? search functionality. Currently the search tool isnt as great and we need to access other documents to identify document name/number and then search on Greenlight. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? They help through a lot of RA/QA and FDA process-related problem-solving. Review collected by and hosted on G2.com. Show More 6/10/2026 Validated ReviewerIncentivizedSource: G2 invite on behalf of seller ![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.) 11/16/2021 "GreenLight Guru QMS" 4.5/5 What do you like best about Greenlight Guru Quality Management System? Addition of features such as supplier grouping have made the system more functional. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? It would be beneficial for them to add AI to the system which would greatly aid in the search function and retrieving relevant information. The current search function itself is not very good. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? The system aids in standardizing various reports (e.g. Change Control and non-conformance) and ensures all relevant documentation is associated. Tracking QMS related tasks throughout the company and linking with the relevant documents within the system cuts down on multiple and decentralized task lists. Review collected by and hosted on G2.com. Show More 11/28/2025 Current UserValidated ReviewerSource: Organic ![Leslimar P.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Leslimar P.") LP Leslimar P. Inventory control Mid-Market (51-1000 emp.) 11/24/2025 "All-in-One Training Tools That Exceed Expectations" 5/5 What do you like best about Greenlight Guru Quality Management System? Excellent server that offers the necessary training tools in one place. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? I don't dislike anything about it 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? It's a platform where you have all your training at your fingertips. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: Organic ## 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(462) [ 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);)