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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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Quality Management Software (QMS Software)

MedTech is complex.
Your QMS shouldn’t be.

Greenlight Guru’s eQMS is purpose-built to help medical device companies develop and manage devices throughout the entire product lifecycle.

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Trusted by 1000+ medical device companies

Do you know what your current system is really costing you?

According to the 2025 Greenlight Guru Benchmark Report, 34% of post-market teams uncovered critical process gaps during audits, revealing issues they hadn’t even known existed. Greenlight Guru was built to fix that.

Scale without roadblocks

Work in a system that centralizes quality, product development, training, and suppliers, for growth without the pains.

Compliance you can count on

Use workflows aligned with FDA, EU MDR, and ISO standards that keep you organized and compliant.

Onboard fast, prove value faster

Failed implementations kill momentum. Get audit-tested templates, expert onboarding, and improved workflows from day one.

Launch with confidence

Eliminate delays and disconnected docs with design controls that link risk and quality, helping keep development on track.

Unite your product and quality teams

For Quality Teams

Compliance shouldn’t slow you down. Greenlight Guru gives you complete control over quality events, training, and document workflows, so nothing falls through the cracks.

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For Product Development Teams

You got into MedTech to build, not push paper. Get design controls that connect to risk and the rest of your QMS to keep you fully traceable and focused on the work that matters most.

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The smarter way to scale your quality system

A single system for the entire
device lifecycle

Whether you’re bringing a device to market for the first time or managing a portfolio of products,
you need a QMS that keeps you organized and compliant at every step.

Design controls that build your DHF for you

Carry out design and development in one connected system. Link user needs, inputs, outputs, verifications, and validations automatically to create a living DHF that stays inspection-ready from day one.
Explore Design Controls
Design Controls

The smarter way to scale your quality system

A single system for the entire
device lifecycle

Whether you’re bringing a device to market for the first time or managing a portfolio of products,
you need a QMS that keeps you organized and compliant at every step.

Be confident in your compliance.

of teams lack confidence
in their ability to manage global compliance at scale.
+
When Canterbury Scientific needed a QMS to keep them compliant and audit-ready in both the US and the EU, they switched from paper to Greenlight Guru.
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“What used to take us six weeks takes a much shorter period of time. In terms of cost, what we pay to have Greenlight Guru is repaid in efficiency.”
— Clive Seymour, CEO

The problems are complicated. The solution is simple.

Boost collaboration and eliminate preventable delays with a validated QMS solution
that’s built specifically for medical device companies.

Always audit-ready

Maintain complete traceability and version control in one system and stay ready for any inspection, any time. 

Efficient compliance

Automate quality tasks like
training, changes, and CAPAs
so you can stay compliant with less manual work.

Accelerate development

Speed up product development with built-in design controls and risk management that improve team collaboration.

Growth on your terms

Support new teams, products, and markets with a QMS that scales as fast as you do.

“Purchasing Greenlight Guru was the best decision for our needs. Their easy-to-use eQMS, SOP Templates, and expert Guru guidance were key to us being able to successfully navigate all of our audits this year”
Amanda Feddersen
QA Manager, Monitored Therapuetics Inc.
“There are a lot of dependencies that occur in every part of a quality system. Greenlight Guru is a fantastic software because it addresses each one.”
Morris Sherwood
Regulatory Compliance, Zyris
“Greenlight Guru's Design Controls module is powerful and the traceability present across the entire QMS is my favorite part about the software. It makes remote collaboration so much more effective.”
Crystal Womack
Quality Manager, Avenda House

Frequently asked questions

What is the implementation process for Greenlight Guru?

The process for implementing Greenlight Guru’s QMS software will depend on the state of your current quality system. If you’re starting from scratch, Greenlight Guru’s onboarding and implementation team will help you build out a new QMS within the system with the help of 80+ audit-tested and customizable SOP templates. If you’re migrating an existing QMS, the O&I team will help you formulate a plan for migration and guide you in prioritizing the most important elements of your QMS.

How do I justify the cost of QMS software to leadership or the board?

The purchase of a new QMS solution is an investment, and the returns on that investment come from many different areas of your business. When they choose a purpose-built QMS solution, medical device companies typically see fewer audit findings, faster submissions timelines, and a reduction in time spent managing the QMS. For larger companies, the gains in efficiency can be substantial. For startups, an airtight QMS shows they are ready for growth and have dependable processes and systems in place, which has a direct impact on valuation.

Do I need a QMS if we haven’t launched our product yet?

Yes, you do need a QMS prior to launching your product. Design and development must be documented within your QMS, and you will be audited to ensure that your QMS is compliant. Having a system in place that supports compliance from day one is one of the most important steps you can take to ensure your company’s long-term success. Greenlight Guru’s QMS solution is built to meet you where you are now, and grow with you as you scale. Right-sized pricing and pre-built templates ensure that you get what you need now—and later on when you’re ready to grow.

Why can’t we keep doing this on Excel?

Companies often choose to begin their QMS on spreadsheets because it’s the cheapest option. However, spreadsheets don’t scale. They create enormous amounts of time-consuming work, they lack built-in traceability, and they introduce the possibility for human error at every step. Greenlight Guru offers a centralized and up-to-date system for all your documents and records, and it includes version control, Part-11 compliant e-signatures, and built-in regulatory alignment to ease the burden of compliance as you grow.

Will Greenlight Guru work for my type of device or business model?

Yes. Greenlight Guru is suited for all types and classes of devices, from traditional lines of surgical tools to SaMD, IVDs, and everything in between. Our audit-tested templates and workflows will help keep you compliant and your business running smoothly regardless of your device type or risk class.

What if our team’s workflow doesn’t match yours?

While Greenlight Guru’s workflows are built to facilitate regulatory compliance for medical device companies, they are still flexible and offer configurations and modular workflows that adapt to your team’s specific needs. Some QMS providers offer endless customizations that initially seem like freedom, but they quickly become a burden when you factor in the time spent validating those changes to the system.

Why should we choose a MedTech-specific solution over a larger provider that serves multiple industries?

The regulatory requirements for medical devices are different than those for pharmaceuticals, aerospace, automotive, or any other industry that other QMS vendors serve. Greenlight Guru provides modules and workflows that are aligned with medical device regulations and standards, such as the FDA’s QSR, EU MDR, ISO 13485:2016, and ISO 14971:2019. And when our customers have questions, they’re answered by medical device industry experts with a deep understanding of both the industry and our software.

What makes GG different from just “another tool” that no one uses?

Greenlight Guru replaces scattered, disconnected tools like Dropbox and Excel with a single, centralized source of truth for everyone who works with the QMS in any capacity. Because the software is intuitive and easy to use, even companies that have had trouble getting buy-in with old QMS systems tend to find their teams quickly adopt Greenlight Guru.

Will Greenlight Guru integrate with our existing tools (e.g., ERP, Jira, etc.)?

Yes. Greenlight Guru’s extensive suite of flexible APIs allows you to share your critical QMS data with outside applications, and Greenlight Guru has a growing library of integrations with tools like Jira and SSO applications.

Focus on the work that matters most

Get a personalized software demonstration and see how Greenlight Guru eliminates repetitive, low-value tasks.

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