10 best QMS software solutions for 2026 | Greenlight Guru

The choice of an electronic quality management system (eQMS) is a critical one for any medtech company. Your quality system will have a direct impact on how quickly you can get high-quality medical devices to market, as well as your ability to pass audits and remain compliant.

The best QMS software solutions will drive you toward excellence by offering access to reliable quality data, and allow you to demonstrate closed-loop traceability at any time. But as the medical device industry and regulatory environments continue to evolve, it's critical that your QMS is built to evolve with the medtech industry.

That evolution has moved quickly over the past year. Nearly every vendor on this list now leads with artificial intelligence, and the claims range from genuinely useful to workflow configuration wearing a new label. One ships no AI at all. Sorting out which is which has become a real part of the evaluation.

There are plenty of different QMS software solutions on the market right now, and while most of them can work for a medtech company, not all of them excel at doing the job. In this article, we'll break down some of the most popular options, where they excel, and what their drawbacks are. We've ordered them by how completely each one covers medical device quality management from design through post-market, which is why a few well-known names appear lower than you might expect.

Given that you're reading this on Greenlight Guru's website, you're probably thinking that we'll be rating ourselves pretty highly. And you're right, but only because our customers do, too. As you'll see, we're also honest about where our strengths and our weaknesses lie.

BONUS RESOURCE: Download your free eQMS Buyer's Guide now!

Best quality management software for 2026 (and beyond)

There are too many QMS software solutions on the market to list them all, but we've chosen what we believe are 10 of the best QMS solutions for a variety of different needs. As you'll see, there are pros and cons to every option, even Greenlight Guru, so it's important to continue doing research once you believe you've found the right option for your organization.

1. Greenlight Guru

Built specifically for medtech, with a customer success team made up of medical device professionals with 100+ years of combined experience, Greenlight Guru is the top pick for any medtech company, from pre-market startups to enterprise organizations.

Pros of using Greenlight Guru:

• Built-in compliance with medical device-specific regulations in both the US and EU, as well as standards like ISO 13485:2016 and ISO 14971:2019.
• Pre-validated out of the box, so there is no separate validation project to run before the system can be used for regulated work.
• Highly responsive customer support with deep medtech experience can provide as much (or as little) support as your organization needs.
• Powerful design controls and risk management software that is fully connected and provides end-to-end traceability.
• Connects directly to Jira and GitHub, so engineers keep working where they already work and their commits, issues, and sprints link back to design control records without anyone re-entering the same information twice.
• AI aimed at the work that creates audit risk rather than at demos. Trace links surface as your team works on the design board. A verifiability check reads design inputs as they are written and flags the ones nobody will be able to test later. Change order summaries that took 20 minutes get drafted in seconds. Every output is a suggestion your team accepts, edits, or throws out.
• Ask a question in plain language and get an answer from your own quality data, without exporting anything or knowing which module to open first. Teams already using their own AI tools can connect them directly to the quality system rather than working around it.

From G2 reviews: "Greenlight Guru has been a game changer for my company. We transitioned to Greenlight Guru and our productivity has increased tremendously. It is a one-stop shop for all of our QMS needs: from design controls, to risk management, to document and change management, to CAPA and nonconformance management and so on. On top of this, their customer support is unmatched."

Drawbacks of using Greenlight Guru:

• Medtech focus makes it not suitable for companies in other industries, like pharma or aerospace.

From G2 reviews: "There are some inconsistencies within Greenlight Guru workspaces. As an example, some field entries require the user to save, but others do not, and some workspaces use RTF text boxes while other workspaces do not."

2. MasterControl

MasterControl is an established provider of cloud-based QMS solutions, primarily serving regulated industries like life sciences and pharmaceuticals. Its platform offers a suite of tools for document management, training, audits, and regulatory compliance.

Pros of using MasterControl:

• MasterControl is widely used in the pharmaceutical industry.
• Enterprise system integrations provide value for larger organizations.
• An industry-agnostic approach means MasterControl's QMS software is customizable to fit the needs of a wide variety of industries.

From G2 reviews: "The most helpful thing about QMS in MasterControl is the ability to deliver quality in a centralized system. The system provides methods of control that supersede what a paper system offers and allows the ability to manage workflows and documents easily."

Drawbacks of using MasterControl:

• Heavy customization is required to get the system compliant and functional for medtech companies.
• Customizations lead to longer and more difficult system validations and drive up the total cost of ownership, which is already one of the highest to begin with.
• Implementation is known to be time-consuming and difficult given the customizations that need to happen within the system before customers can begin using it.

From G2 reviews: "Some modules are easy to understand, and others require more time and workarounds to bring the system up to speed for particular company needs. An enhancement is always helpful but is not provided immediately, so a user has to track backward to make changes."

3. ETQ Reliance

ETQ is a provider of a modular QMS platform called ETQ Reliance, which is used across various industries, including manufacturing, life sciences, and food and beverage. The system offers capabilities in managing compliance, risk, and quality processes, with features like document control, audit management, and CAPA.

Pros of using ETQ Reliance:

• The modular approach to a QMS is customizable and offers users flexibility in how they approach building their QMS.

From G2 reviews: "The app selection is extensive and can be expanded on, and comes with basic functionality. With the right internal admin and designer resources, a lot of smaller modifications can be performed, and ETQ offers packages for further rollout stages with their experienced implementation staff."

Drawbacks of using ETQ Reliance:

• Extensive customizations and the ensuing validation can complicate implementation and ongoing work within the system.
• High upfront and ongoing costs create higher total cost of ownership, which smaller companies may find prohibitive.
• Reports of slow responses to software bugs and other customer service issues.

From G2 reviews: "Learning the process of how everything works in ETQ can be very difficult. Routing a document through the entire system the first time can be daunting, since there is a lot going on."

4. DotCompliance

DotCompliance provides a cloud-based QMS solution built natively on the Salesforce platform, focusing on regulated industries such as life sciences and pharmaceuticals. The platform offers a range of pre-configured solutions for regulatory compliance.

Pros of using DotCompliance:

• Since the system is built on Salesforce, it integrates easily with existing Salesforce environments.
• Comes with pre-configured templates and workflows.

From G2 reviews: "The home dashboard area is useful for providing an overview of all areas of the platform. Open trainings and similar items are clearly visible immediately upon opening DotCompliance, which helps make sure they are not forgotten."

Drawbacks of using DotCompliance:

• The Salesforce dependency cuts both ways, as companies that are not already heavily invested in Salesforce will need to consider the cost of adding it to their tech stack. That dependency shows up in daily work too. Document checkout runs through Salesforce's own office suite rather than your Microsoft 365 tenant, there is no Teams support, and documents are capped at 20MB each.
• Customization is complex, especially for those with highly specific quality processes.
• Several capabilities a device company would consider core, including design controls, regulatory, and clinical, are sold as separate annual add-ons on top of per-seat licensing. The pitch is that you will not outgrow the platform, and that is true in the sense that you will keep buying more of it.
• The platform requires two paid administrator licenses before anyone else gets access.

From G2 reviews: "The way in which documents are displayed can be confusing. The document version displayed when a file is open is not always the most recent or effective version, which introduces a risk of relying on an outdated SOP for those who are not aware."

5. QT9 QMS

QT9 is a modular quality management platform used across medical devices, manufacturing, aerospace, and food and beverage. Buyers select the modules they need, and unusually for this list, it offers an on-premise deployment alongside the cloud product.

Pros of using QT9 QMS:

• A modular structure, so buyers license and configure only the modules they select.
• Multi-site capability.
• Validation performed by the vendor and included, rather than run as a separate project by the buyer.

From G2 reviews: "The system is intuitive and easy to use, which has helped improve training efficiency and overall employee engagement."

Drawbacks of using QT9 QMS:

• Reporting is a recurring complaint. Users describe pulling data out into Excel to build the metrics they want rather than getting them from the platform directly.
• Reviewers describe the change control process as complicated to manage.
• Record linking has structural limits. Users report being unable to connect multiple inspections to a single nonconformance, or multiple nonconformances to a single corrective action.
• Getting started takes real effort. Reviewers consistently mention the time needed to learn the full module set, and some found self-directed work in the sandbox more useful than the vendor's training sessions.
• The interface looks dated next to newer platforms.

From G2 reviews: "There are some industry-wide best practices for ISO 13485 that are not met, notably for CAPA and other processes where multiple approvals by stage are best practice."

6. Grand Avenue Software

Grand Avenue is a smaller quality management vendor based in St. Paul, Minnesota, serving post-market medical device companies. It competes primarily on price, and the modules are basic by design.

Pros of using Grand Avenue Software:

• Lower licensing cost than most of the platforms on this list.
• Basic modules that are straightforward to learn.
• 21 CFR Part 11 support, along with workflows for process engineering and manufacturing line operations.

From G2 reviews: "You do not have to use every module for the software to be effective for your company. It is ideal for smaller to mid-sized medical device companies."

Drawbacks of using Grand Avenue Software:

• The system is not validated out of the box. You will need an internal or outsourced validation project before it is usable for regulated work, which is real cost and real delay on top of licensing.
• Implementation timelines are measured in months rather than weeks, which is a long time to wait if a submission or an audit is on the calendar.
• Documents cannot be viewed inside the platform. Every one has to be downloaded to open.
• Training functionality is basic, and tracking and evidence collection get harder as headcount grows.
• No multi-level design controls, no requirements management, and no living design history file, so teams building toward a submission tend to outgrow it.
• Regulatory updates are a manual lift rather than something the platform maintains for you.

From G2 reviews: "There is limited ability to add additional security features to document control, like watermarking or removing access to the edited version of a released document, and limited ability to customize metrics based on available data fields. Not all QMS modules are available, including batch records and non-document change control."

7. Qualio

Qualio is a cloud-based QMS designed specifically for startups and small-to-medium-sized businesses in the life sciences, as well as cannabis and pharmaceutical industries. The platform focuses on simplifying quality management processes, allowing companies to manage compliance, documents, and training. Over the past year it has added design control dashboards, a custom framework builder, and an AI feature that scans a quality system clause by clause against a standard to find gaps.

Pros of using Qualio:

• The entry tier covers document control and training with minimal setup.
• Basic document management functionality can work for a variety of industries, like cannabis or pharmaceutical.
• Separate production and sandbox environments let teams test process changes before they go live.

From G2 reviews: "Having two different working environments, for example, a production environment and a sandbox for trial and learning, is really helpful."

Drawbacks of using Qualio:

• Almost everything that differentiates the platform, including the AI gap-scanning, the custom framework builder, and API access, sits behind the top pricing tier. The entry tier is a document control tool, which means the capabilities that drew you in only arrive once you have moved up to enterprise-level pricing.
• Design controls and risk management are not connected to each other with the depth a device company needs, so a fair amount of the work still happens outside the system.
• Document management is a frequent user complaint, specifically finding, updating, and exporting documents from the system. Documents export as PDF rather than Word, which becomes a problem the first time you need to hand a supplier an editable file.
• Limited features for larger organizations.

From G2 reviews: "There are obstacles such as difficulty updating older documents, restricted formatting and audit trail options, an inadequate dashboard with missing functionality, frequent session timeouts, and a tedious login process, though the login process does enhance security."

8. Matrix Req

Matrix Req, the QMS product sold by Matrix One, is an application lifecycle management (ALM) tool with a compliance framework layered on top of it. It is sold to engineering-led teams working on software-heavy devices. It is worth understanding what it is before you evaluate it as a quality system, because it started as an engineering tool and the quality layer came afterward.

Pros of using Matrix Req:

• ALM functionality covering multi-layered verification and validation for software devices.
• Handles variant and branch management for requirements hierarchies.
• Concurrent licensing charges for simultaneous users rather than total seats.

From G2 reviews: "Once familiar with the system, accessing documents, records, training, and other modules is quite smooth. It is reliable and performs well for routine activities, including handling a large volume of quality and compliance records."

Drawbacks of using Matrix Req:

• It arrives close to a blank slate. Core quality processes have to be configured and validated by hand before the system does anything for you, and that is a substantial project in both time and internal resource.
• Built by developers for developers, which shows. QA and RA teams routinely find it hard to get into, and the learning curve is steep enough that adoption stalls in the teams who need the system most.
• No Jira integration, which is a strange gap in a tool aimed at engineering-led companies and means your developers are still working in two places.
• Document management and change control are weak relative to the rest of the platform, and users report slow performance.
• Because the configuration burden is front-loaded, some teams abandon the implementation partway through and end up back on manual systems.

From G2 reviews: "The main drawbacks are a steep learning curve, a less polished interface, and complex template editing. New users require proper onboarding, customizing reports often requires technical knowledge, test execution can feel dated and involve too many steps, and large projects may experience slower traceability views and document generation."

9. Veeva QuickVault and Veeva Vault

Veeva is a cloud-based software company serving the global life sciences industry. It sells two quality products relevant to device companies. Veeva Vault is the enterprise platform used by large pharma and biotech. QuickVault is a stripped-down, medtech-only product with a narrower feature set, and it is the one most device companies will be comparing.

Pros of using Veeva QuickVault and Veeva Vault:

• A regulatory compliance framework with support for U.S. Food and Drug Administration (FDA) regulations and ISO standards.
• QuickVault has no implementation or validation fees and is billed month to month.
• Vault is widely used across large pharmaceutical and biotech organizations.

From G2 reviews: "The platform is pretty easy to navigate. For more basic functions, it is simple to use."

Drawbacks of using Veeva QuickVault and Veeva Vault:

• QuickVault ships no AI at all. Their own representatives suggest running a separate AI tool alongside it.
• Integrations are limited at every QuickVault tier, so connecting your quality system to engineering or manufacturing tools means working around it.
• QuickVault's simplicity comes from capability that was taken out. Outgrow it and the path forward is Vault, which is expensive for smaller companies, has a steep learning curve, and requires customization work that is time-consuming to get right.

From G2 reviews: "Some features overlap with other Veeva solutions, which can make it confusing for businesses to decide which tool to use. The platform is also on the pricey side."

10. Ketryx

Ketryx is a traceability and compliance layer that connects to Jira and GitHub and generates documentation records from engineering activity, with release gates that check traceability before code ships. The company markets itself as an AI platform for regulated product development.

Pros of using Ketryx:

• Integrates with Jira and GitHub.
• Covers software-specific requirements including IEC 62304, software of unknown provenance (SOUP), software bill of materials (SBOM) generation, and cybersecurity documentation.
• Includes AI agents, change impact assessment, and Model Context Protocol (MCP) integration.

From G2 reviews: "Ketryx has been integral in our ability to develop and release compliant software in an integrated fashion. It connects the tools our team is already using and comfortable with."

Drawbacks of using Ketryx:

• It is a traceability and documentation layer rather than a complete quality system. CAPA, supplier management, training management, complaint handling, and structured document control are not there, which means a parallel tool for everything a QA team actually runs day to day.
• Risk management is handled as a flat table and cannot carry multiple frameworks in parallel. A team running ISO 14971, FMEA, and cybersecurity risk at the same time will end up maintaining duplicate matrices.
• The entire value story assumes your team uses Jira and GitHub with real discipline. If tickets are thin or commits are unlinked, the compliance record built from them is thin too.
• The company has expanded into automotive, aerospace, defense, and nuclear energy, which raises a fair question about how much of the roadmap stays pointed at medical devices.

From G2 reviews: "It is a newer tool and many features are still being built out."

How to choose the best QMS software for your company

As you're deciding on the best QMS software for your business, one of the most important considerations is the customer base of each QMS solution. Most of the QMS solutions on the market are built to serve a variety of industries. Some are specific to life sciences, already a large category, while others are industry agnostic and require extensive customization for medtech. These companies may also be serving customers in the aerospace, automotive, food and beverage, or cannabis industries.

This does not mean they cannot be used for medtech, but it does add another layer of complexity to the purchase, implementation, and continual upkeep of the system. It also tends to lead to less intuitive interfaces and workflows, especially in areas like design controls and risk management. Customers often find that these tools are like fitting a square peg in a round hole. You can make it work, but the added effort you have to put in may not be worth it.

Ask what you have to build yourself

Several systems on this list arrive as a framework rather than a working quality system. You configure the processes, you validate them, and only then does the software do anything for you. That work is real, it lands on people who already have day jobs, and it happens before you see any benefit. Ask any vendor what their product does on day one without configuration, and ask whether validation is included or something you arrange separately. The answer separates the platforms more cleanly than any feature list will.

Ask what the AI actually does

Nearly every vendor on this list will open with artificial intelligence. The claims are doing very different work depending on who is making them. Some of it is genuine automation of tasks that used to eat hours. Some of it is conditional logic that existed before anyone called it AI.

What specific task does the feature remove, and how long did that task take before? Is it available to you today at the tier you are actually buying, or only at the one above it? And does it produce something a human reviews and owns, or does it make the decision for you? In a regulated environment, the third question is the one auditors will care about. Anything that ends up in your quality system needs a person who can defend it.

Build the business case

Often more important than which eQMS to choose is navigating organizational policies and determining when and how to implement the solution. This decision, and the process to get there, often holds up teams on their journey, so we've put together some resources for internal stakeholders who need to determine return on investment (ROI), explain implementation timelines, and build a business case for an eQMS.

Choosing a purpose-built QMS solution

There are QMS solutions, like Greenlight Guru, that are purpose-built for a single industry. In our case, that's medtech. Our software was carefully crafted to support the unique needs of medical device companies. And while that makes it unsuited for industries like aerospace or cannabis, that's by design.

Our medtech-specific modules cover the entire medical device product lifecycle, and our software comes pre-validated with built-in compliance with the latest regulations and standards, like the U.S. Food and Drug Administration's (FDA) Quality Management System Regulation (QMSR), the European Union Medical Device Regulation (EU MDR), and ISO 13485:2016. It stays current as those regulations and standards evolve.

Greenlight Guru is built to help you stay compliant and maintain closed-loop traceability between design controls, risk management, design reviews, and postmarket surveillance activities throughout the total product lifecycle. That's why we believe a purpose-built QMS solution like Greenlight Guru will always be the superior choice for medtech companies of all sizes and stages.

BONUS RESOURCE: Download your free eQMS Buyer's Guide now!

The best QMS software makes quality your competitive differentiator

The choice of a QMS solution is so important because the right QMS software will act as an accelerator for your business, automating and simplifying quality activities, increasing collaboration and visibility during design and development, and reducing the stress of audits.

At Greenlight Guru, we believe that our purpose-built solution is the best QMS software for medical device companies of all types because we built it specifically for this industry.

So, if you're a medical device company and ready to see how a purpose-built QMS software can help you pass audits, grow your business, and bring your devices to the patients who need them most, then get your free demo of Greenlight Guru today.

Keep reading

If you are building out your QMS selection process, these related guides go deeper on the specific components:

• eQMS buyer's guide: making the business case for a new QMS solution
• How to implement a QMS: implementation plan and steps
• QMSR vs. QSR: what FDA's ISO 13485 harmonization changed for medical device companies
• ISO 13485 and FDA QMSR: complying with QMS requirements
• Postmarket surveillance for medical device companies