Audience

Medical Device, Quality Management, QMS, Product Development, Quality, Regulatory

About Greenlight Guru

Trusted by over 1,000 medical device manufacturers, Greenlight Guru is a quality management system built for the medtech industry. The platform is architected around regulatory reality, not generic enterprise frameworks. FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 11 are aligned at the foundation, not added later.

Implementation takes weeks, not quarters. With 80+ audit-tested templates and medtech-expert support, you skip the separate validation project and go live faster.

Greenlight Guru integrates AI-powered automation to reduce manual work while maintaining the audit trail and documentation rigor your business requires.

With 15 years in medical device QMS, Greenlight Guru helps you pass inspections, accelerate time-to-market, and sustain commercial success.

Pricing

Pricing Details:
Modules:
Document Management
Change Management
Training Management
Supplier Management
Design Controls
Risk Management
Parts Management
Quality Events
Software Parts
Software Release Management
SBOM Management
Software Test Automations

Pricing is custom scoped.

Integrations

Ratings/Reviews - 11 User Reviews

Overall 4.3 / 5
ease 4.4 / 5
features 4.4 / 5
design 4.3 / 5
support 4.3 / 5

Company Information

Greenlight Guru
Founded: 2013
United States
greenlight.guru

Videos and Screen Captures

Design Control Software

Design Control Software

Other Useful Business Software
Build Securely on AWS with Proven Frameworks Icon
Build Securely on AWS with Proven Frameworks

Lay a foundation for success with Tested Reference Architectures developed by Fortinet’s experts. Learn more in this white paper.

Moving to the cloud brings new challenges. How can you manage a larger attack surface while ensuring great network performance? Turn to Fortinet’s Tested Reference Architectures, blueprints for designing and securing cloud environments built by cybersecurity experts. Learn more and explore use cases in this white paper.
Download Now

Product Details

Platforms Supported
Cloud
Training
Documentation
Live Online
Webinars
Support
Phone Support
24/7 Live Support
Online

Greenlight Guru Frequently Asked Questions

Q: What kinds of users and organization types does Greenlight Guru work with?
Q: What languages does Greenlight Guru support in their product?
Q: What kind of support options does Greenlight Guru offer?
Q: What other applications or services does Greenlight Guru integrate with?
Q: What type of training does Greenlight Guru provide?
Q: What pricing for support is available for Greenlight Guru?
Q: What pricing for training is available for Greenlight Guru?

Greenlight Guru Product Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Document Control
ISO Standards Management
Risk Management
Supplier Quality Control
Training Management
Defect Tracking
Equipment Management
Maintenance Management

Greenlight Guru Additional Categories

  • A Greenlight Guru User
    Specialist, Regulatory Affairs
    Used the software for: 6-12 Months
    Frequency of Use: Daily
    User Role: User
    Company Size: 100 - 499
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "Could use some improvement "

    Posted 2026-09-22

    Pros: Easy to search, easy to navigate, like that is accessed via web. The pricepoint is competitive compared to other platforms. It is ISO 13485 compliant

    Cons: CO process is very complicated, the uploading process and the "checking out" of the documents is very complicated. there is no collaboration workflow. It requires word documents for some aspects of the CO, but PDFs for other. Very hard to get it right without the intervention of documents control. Should include an option to allow user to see redlines from the documents page, rather than having to download the CO packet.

    Overall: It has great potential, most concerns are from the CO process. It can use some features that can help guide the user and make the process more linear, rather than uploading many things at once.

    Read More...
  • A Greenlight Guru User
    Engineer
    Used the software for: Less than 6 months
    Frequency of Use: Monthly
    User Role: User
    Company Size: 20,000 or More
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "Review: GGuru "

    Posted 2026-09-10

    Pros: Easy UI.
    Great theme; professional.
    Very well structured.
    Easy to navigate.
    Great reminder feature.

    Cons: Would love an AI summary feature to quickly summarize long documents when feasible

    Overall: Please straight forward application to use. A bit outdated when it comes to AI technology. But overall great software

    Read More...
  • A Greenlight Guru User
    QA
    Used the software for: Less than 6 months
    Frequency of Use: Monthly
    User Role: User
    Company Size: 1,000 - 4,999
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "It was good"

    Edited 2026-09-11

    Pros: Very helpful, easy to use, valuable experience, and definitely worth the investment. Helpful, useful, easy to use, and worth the investment.

    Cons: No major issues found so far; overall experience has been positive and satisfying.No major issues experienced so far.

    Overall: Excellent experience. Useful, reliable, and worth it. Highly recommended! ⭐⭐⭐⭐⭐Great experience, highly recommended.

    Read More...
  • A Greenlight Guru User
    Senior Engineer
    Used the software for: 6-12 Months
    Frequency of Use: Weekly
    User Role: User
    Company Size: 1 - 25
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "A very worthwhile eQMS"

    Posted 2026-09-10

    Pros: Greenlight Guru takes a lot of the manual stress out of maintaining a DHF and QMS, and it makes audits noticeably easier to prepare for and get through. The structure it enforces around documentation is genuinely useful, especially compared to more ad hoc systems.

    Cons: As someone who joined a company with an already well-established QMS in Greenlight Guru, I found the sheer volume of files a bit daunting to navigate at first. The system relies heavily on filters and groupings that someone else has already set up, so if you don't already know what you're looking for, it can be hard to find your way around. A more traditional tiered/folder-style view would have made it much easier to explore and orient myself, especially as a newer user.

    Overall: A solid QMS platform that clearly earns its keep when it comes to DHF management and audit readiness. It's not the most intuitive system to explore if you're new to an existing setup, but once you know where things live, it does its job well. I'd recommend it, with the caveat that new users may need a bit of onboarding support to get comfortable navigating it.

    Read More...
  • A Greenlight Guru User
    Project Manager
    Used the software for: Less than 6 months
    Frequency of Use: Monthly
    User Role: User
    Company Size: 5,000 - 9,999
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "Very Good QMS"

    Posted 2026-09-10

    Pros: Purpose-built for medical device companies, with workflows aligned to industry regulations and standards.
    Strong document control and traceability, making it easier to manage audits and maintain compliance records.
    Centralized platform for quality management, training, CAPA management, audits, and risk processes.
    User-friendly interface that helps teams find information quickly and manage activities from a single dashboard.
    Good visibility and reporting, helping organizations stay audit-ready and monitor quality activities efficiently.
    Scalable solution that can grow alongside an organization's quality and compliance requirements.

    Cons: Initial implementation and configuration can require time and planning, particularly for organizations migrating from paper-based or legacy systems.
    Training is needed to fully utilize all features, especially for less frequent users.
    Pricing may be a consideration for smaller organizations or start-ups, depending on budget constraints.
    Some advanced processes and workflows may feel complex until users become familiar with the platform.

    Overall: Greenlight Guru is a mature and capable quality management platform that delivers significant value for regulated medical device organizations. Its strength lies in combining quality, compliance, training, document control, and product development processes within a single system. While there can be a learning curve during implementation and adoption, the long-term benefits of improved traceability, audit readiness, and process consistency generally outweigh the initial effort. Overall, Greenlight Guru is a strong choice for organizations looking to modernize and streamline their quality management processes while supporting regulatory compliance.

    Read More...
  • A Greenlight Guru User
    Clinical Research Associate
    Used the software for: 6-12 Months
    Frequency of Use: Weekly
    User Role: User
    Company Size: 26 - 99
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "Excellent tool for QM"

    Edited 2026-09-09

    Pros: I like the usability of this platform, which makes it easy for me to find relevant documents with search functions.

    Cons: There are times when there are too many buttons to push to complete a task, for example, when completing training.

    Overall: GreenLightGuru has provided a very good experience overall. I benefit from it in my position because I do not spend unnecessary time sifting through documents unrelated to my task.

    Read More...
  • A Greenlight Guru User
    Recruiting Coordinator
    Used the software for: 6-12 Months
    Frequency of Use: Yearly
    User Role: User
    Company Size: 100 - 499
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "Happy User"

    Posted 2026-09-02

    Pros: The system is user-friendly, easy to navigate, and provides helpful tools that simplify day-to-day tasks. I especially appreciate how everything is centralized, which makes it easier to stay organized and keep track of important information.

    Cons: There can be a lot of notifications, and some pages are slower than others.

    Overall: It is user-friendly, organized, great for maintaining documentation and compliance, and helps streamline workflows and collaboration. Some processes can feel overly complicated, and customization could be improved. It can also be expensive for smaller organizations.

    Read More...
  • Dipali T.
    Quality Engineer
    Used the software for: Less than 6 months
    Frequency of Use: Weekly
    User Role: User
    Company Size: 1,000 - 4,999
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "Excellent eQMS Platform for Learning and Quality Management"

    Posted 2026-09-02

    Pros: Greenlight Guru is a very user-friendly and well-organized platform. It provides a great environment to learn quality management processes and understand regulatory requirements. The system is easy to navigate, and the available features help teams manage documentation, compliance activities, and quality processes efficiently. I especially appreciate how the platform supports continuous learning and improves understanding of quality management best practices.

    Cons: The platform includes many features, which can take some time for new users to fully explore and become familiar with. Additional beginner-focused tutorials could further improve the onboarding experience.

    Overall: My experience with Greenlight Guru has been very positive. It is a reliable and effective eQMS solution that helps organizations manage quality processes while also providing valuable learning opportunities for users. The platform is intuitive, well-structured, and makes it easier to maintain compliance and documentation. I would recommend Greenlight Guru to teams looking for a robust quality management system with strong usability and educational value.

    Read More...
  • Celine L.
    Service marketing manager
    Used the software for: 6-12 Months
    Frequency of Use: Monthly
    User Role: User
    Company Size: 20,000 or More
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "Easy to Use and Helpful for Quality Management"

    Posted 2026-09-01

    Pros: The platform is straightforward and easy to navigate. I especially like having training assignments, documents, and completion status organized in one place.

    Cons: Occasionally, the login or password reset process could be smoother. Improving that experience would make the platform even easier to use.

    Overall: Greenlight Guru is easy to navigate and provides a convenient way to manage quality-related documentation and training. Overall, it has been a reliable and user-friendly platform for our quality management needs.

    Read More...
  • A Greenlight Guru User
    Senior manager
    Used the software for: Less than 6 months
    Frequency of Use: Weekly
    User Role: User
    Company Size: 1 - 25
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "QMS review"

    Posted 2026-09-01

    Pros: Easy to maneuver and operate, with a user-friendly design that makes it simple to navigate and handle. It provides a smooth, convenient experience without requiring much effort.

    Cons: The controls may take a little time to get used to.

    Overall: Overall, it is a good and reliable option, offering easy handling, smooth operation, and a convenient user experience.

    Read More...
  • A Greenlight Guru User
    MDT
    Used the software for: Less than 6 months
    Frequency of Use: Weekly
    User Role: User
    Company Size: 26 - 99
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "Great product"

    Posted 2026-09-01

    Pros: Easy to navigate and easy to use. It was really straightforward to learn how to use the product and complete what I needed to.

    Cons: Honestly, there isn't much I didn't like. It works well!

    Overall: I had a great experience with this product. It is used across my team and we all were able to integrate it into our team very easily.

    Read More...
  • Previous
  • You're on page 1
  • Next