Greenlight Guru has been marketed since 2013 as the first digital eQMS (electronic Quality Management System) designed specifically for Medical Device companies, and its reputation has been growing ever since.
But what’s it like to use today?
Greenlight Guru is a cloud-based QMS platform developed in response to the archaic, paper-based systems that many established medtech companies were still relying on—even as other industries embraced digital transformation.
It offered these companies the digital tools needed to streamline and automate their planning and quality processes, while still meeting the strict regulatory demands of the industry. It helped with documentation and audit preparation required for FDA and ISO 13485 compliance, enabling many companies to bring safer products to market faster.
And its offerings continue to evolve.
In 2025, Greenlight Guru offers two core solutions:
This review focuses on the Quality platform and asks whether it's a good fit for medical device start-ups or SMEs looking for a cost-efficient, compliant QMS to support them from initial concept through to launch.
The functionality Greenlight Guru offers is undeniably powerful. It includes automation features that lighten the load for developers and quality teams. The platform's traceability matrix allows you to input your user needs alongside design and risk data and generates a system that links everything from user needs to verification - supporting compliance with FDA requirements from the start.
This kind of real-time traceability provides digital transparency across the entire product lifecycle, aligning with current best practices for risk management, design control and quality assurance. Users also benefit from structured workflows that, when followed as designed, help ensure nothing slips through the cracks.
Not always.
While Greenlight Guru claims their SOP templates are ready to go, one company found significant gaps during a stage 1 audit and had to rewrite large portions to bring them up to standard. This is not unique to Greenlight - many ‘canned SOPs’ from other vendors suffer the same issue - but it undercuts the platform’s promise of "ready-made" compliance.
The platform’s rigidity is another common criticism. While it aims to offer a complete out-of-the-box solution, that approach can feel overly prescriptive. Some users and quality consultants have noted that Greenlight dictates how core processes like document control should be handled - even when teams have different preferences or commercial needs.
As one consultant put it:
"You have to follow their workflows... and modifying those workflows is very difficult. If their workflow matches the style of your business, great. If not, you’ve got work to do."
This can make the system feel cumbersome for companies who need flexibility or who already have working systems in place.
Additionally, some users report a steep learning curve and a heavier admin burden than expected. While automation helps, setting up and maintaining the system still requires a significant internal resource commitment. Compared to other platforms designed to flex around your process, GLG's structured approach can slow down iteration and increase overhead.
Greenlight Guru is offered in three tiers:
Essentials starts at around $12–15K/year (up to 5 users), but most serious users will need at least the Plus tier, which starts at approximately $30K/year before add-ons.
Pricing is per seat, which can make it costly to offer access across your full team—potentially undermining the idea of a single source of truth for your organisation. There’s also a 3-year minimum contract and no meaningful trial, which means you're making a long-term commitment with no real hands-on evaluation.
Some users also report sharp price increases as they scale. As teams grow and require more user licenses or advanced features, total cost can rise significantly — sometimes doubling. There is little public pricing transparency, and buyers must go through a sales process to receive a quote.
For an exploration of where Greenlight Guru shapes up against its best competitors, read our no-holes-barred review of the top 6 eQMS platform choices for scaling medical device developers
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✅ What’s good |
❌ What to watch out for |
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Industry focus |
Purpose-built for medical device companies—designed from the ground up to meet FDA and ISO 13485 requirements. |
Strong FDA alignment means EU MDR workflows may require extra steps or duplication. |
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Traceability |
Automatically links user needs, risks, design inputs/outputs, and testing. The Traceability Matrix keeps your system audit-ready. |
The way traceability is built is fixed - changing how it works or looks is difficult. |
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Regulatory documentation |
Helps you build and manage a complete Medical Device File, aligned with the latest FDA QMSR and ISO 13485 standards. |
Built-in SOPs often need rewriting—some teams report audit issues using them straight out of the box. |
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Structured onboarding |
Greenlight Guru provides a well-defined framework to help teams build a compliant, audit-ready QMS from the ground up - with support for every step of the process. |
If your team already has established quality practices, fitting them into GLG’s predefined structure can be slow and restrictive. |
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Best fit for growth |
A strong choice for larger or well-resourced teams that can commit the time and effort to implement a new eQMS thoroughly. |
For fast-moving, scaling companies, the system’s rigidity can get in the way—adapting it to fit your needs may require workarounds. |
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Pricing |
Tiered packages to match stages of business (Essentials, Plus, Professional). |
Serious use starts at ~$30K/year. Per-seat pricing makes full-team access expensive and total cost can rise sharply as you scale. |
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Collaboration & visibility |
Central system of record for quality, risk, and design—great for cross-team alignment. |
High user fees discourage full adoption—hurts collaboration if only part of the team has access. Extended free trial is not available |
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Vendor lock-in |
Includes validation support to meet audit requirements. |
Long contracts and limited data export options make switching difficult. |
Greenlight Guru has a strong focus on FDA requirements, particularly generating Design History Files (DHF) and Device Master Records (DMR). However, with the FDA moving toward the ISO-aligned Medical Device File (MDF) model under its new QMSR, that language is evolving.
Meanwhile, companies targeting the EU must still build a Technical Documentation to meet MDR requirements. These don't always map neatly to Greenlight's workflows, leading to duplication of effort and custom workarounds.
Like many enterprise software tools, Greenlight Guru introduces both contractual and technical lock-in. Customers are often tied into multi-year agreements with limited exit options, and the lack of structured data export makes migrating to another eQMS painfully manual.
In other words, once you sign on, changing course can be difficult and expensive—something industry veterans warn about:
“Using a platform like GLG means placing a lot of trust in their expertise—and too often that trust is misplaced. Clients often want someone to prescribe the way to work, so they buy in, spend a great deal of money, then realise how inflexible the system is—and by that point they’re stuck, especially with something like Greenlight.”
Medical Device QMS Consultant
The medical device industry is increasingly embracing Risk-Based Thinking: the idea that your quality system should scale in proportion to the risk your product presents.
For early-stage teams, this means starting lean and building only what you need at each stage. But Greenlight Guru may be too prescriptive - and expensive for this kind of gradual, adaptive approach.
Businesses who commit to GLG in the early stages of their development can also regret the decision further down the line.
“Customers churn off Greenlight because—even in small companies—someone is hired who specialises in corrective and preventive actions and already has a preferred workflow. Greenlight forces its own approach. In addition, its document-control system can’t meet some post-market compliance requirements, leading more mature companies to look elsewhere”
Former Greenlight Guru employee
Some modern EQMS tools are built with this kind of flexibility in mind, offering modular architectures, customisable workflows, and a more intuitive user experience. These platforms allow teams to configure their own processes from the start, rather than conform to a fixed set of workflows. That flexibility can make them more practical for start-ups or SMES looking to stay compliant without being constrained.
There’s no question that Greenlight Guru is a powerful platform. But for some, its high cost, rigid structure, and long commitment make it hard to justify. The good news? More flexible eQMS platforms are now available—designed to grow with your product, your team, and your market.
Blog post updated on 20/05/2025