What is Greenlight Guru?

Greenlight Guru serves more than 1,000 device manufacturers with a quality management system engineered specifically for medtech. Rather than forcing your workflow into a generic platform, the system is architected around regulatory reality. FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 11 compliance is aligned at the core, not added as an afterthought.

Go live in weeks instead of quarters. You get 80+ pre-validated templates and medtech expert guidance, so you skip the separate validation project entirely.

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

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

Pricing

Price Overview:
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.

Screenshots and Video

Design Control Software

Design Control Software

Company Facts

Company Name:
Greenlight Guru
Date Founded:
2013
Company Location:
United States
Company Website:
greenlight.guru
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Product Details

Deployment
SaaS
Training Options
Documentation Hub
Online Training
Webinars
Support
Standard Support
24 Hour Support
Web-Based Support

Product Details

Target Company Sizes
Individual
1-10
11-50
51-200
201-500
501-1000
Target Organization Types
Mid Size Business
Small Business
Startup
Supported Languages
English

Greenlight Guru Categories and Features

Quality Management Software

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

More Greenlight Guru Categories

  • Reviewer Name: A Verified Reviewer
    Position: MDT
    Has used product for: Less than 6 months
    Uses the product: Weekly
    Org Size (# of Employees): 26 - 99
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    Great product

    Date: Sep 01 2026
    Summary

    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.

    Positive

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

    Negative

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

    Read More...
  • Reviewer Name: A Verified Reviewer
    Position: Recruiting Coordinator
    Has used product for: 6-12 Months
    Uses the product: Yearly
    Org Size (# of Employees): 100 - 499
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    Happy User

    Date: Sep 02 2026
    Summary

    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.

    Positive

    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.

    Negative

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

    Read More...
  • Reviewer Name: A Verified Reviewer
    Position: Senior manager
    Has used product for: Less than 6 months
    Uses the product: Weekly
    Org Size (# of Employees): 1 - 25
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    QMS review

    Date: Sep 01 2026
    Summary

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

    Positive

    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.

    Negative

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

    Read More...
  • Reviewer Name: Celine L.
    Position: Service marketing manager
    Has used product for: 6-12 Months
    Uses the product: Monthly
    Org Size (# of Employees): 20,000 or More
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    Easy to Use and Helpful for Quality Management

    Date: Sep 01 2026
    Summary

    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.

    Positive

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

    Negative

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

    Read More...
  • Reviewer Name: A Verified Reviewer
    Position: QA
    Has used product for: Less than 6 months
    Uses the product: Monthly
    Org Size (# of Employees): 1,000 - 4,999
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    It was good

    Updated: Sep 11 2026
    Summary

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

    Positive

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

    Negative

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

    Read More...
  • Reviewer Name: A Verified Reviewer
    Position: Senior Engineer
    Has used product for: 6-12 Months
    Uses the product: Weekly
    Org Size (# of Employees): 1 - 25
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    A very worthwhile eQMS

    Date: Sep 10 2026
    Summary

    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.

    Positive

    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.

    Negative

    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.

    Read More...
  • Reviewer Name: A Verified Reviewer
    Position: Associate Software Engineer
    Has used product for: 6-12 Months
    Uses the product: Weekly
    Org Size (# of Employees): 1,000 - 4,999
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    Excellent Quality Management Solution for Medical Device Organizations

    Date: Sep 23 2026
    Summary

    Greenlight Guru has been a reliable quality management solution that helps simplify compliance and documentation processes. The platform provides excellent traceability, document control, and collaboration features that are particularly valuable for regulated organizations. While there is room for improvement in performance and customization, the overall experience has been positive, and it has helped our team work more efficiently while maintaining compliance requirements.

    Positive

    Easy-to-use interface for managing quality and compliance documentation.
    Strong traceability between requirements, risks, tests, and design controls.
    Centralized document management improves team collaboration and audit preparedness.
    Helpful customer support and onboarding experience.
    Saves time by streamlining regulatory and quality management processes.

    Negative

    Some areas of the platform can occasionally feel slow when working with large datasets.
    Reporting and workflow customization options could be more flexible.
    Initial setup and configuration may require time for new users.

    Read More...
  • Reviewer Name: A Verified Reviewer
    Position: Specialist, Regulatory Affairs
    Has used product for: 6-12 Months
    Uses the product: Daily
    Org Size (# of Employees): 100 - 499
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    Could use some improvement

    Date: Sep 22 2026
    Summary

    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.

    Positive

    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

    Negative

    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.

    Read More...
  • Reviewer Name: A Verified Reviewer
    Position: Project Manager
    Has used product for: Less than 6 months
    Uses the product: Monthly
    Org Size (# of Employees): 5,000 - 9,999
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    Very Good QMS

    Date: Sep 10 2026
    Summary

    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.

    Positive

    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.

    Negative

    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.

    Read More...
  • Reviewer Name: Dipali T.
    Position: Quality Engineer
    Has used product for: Less than 6 months
    Uses the product: Weekly
    Org Size (# of Employees): 1,000 - 4,999
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    Excellent eQMS Platform for Learning and Quality Management

    Date: Sep 02 2026
    Summary

    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.

    Positive

    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.

    Negative

    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.

    Read More...
  • Reviewer Name: A Verified Reviewer
    Position: Clinical Research Associate
    Has used product for: 6-12 Months
    Uses the product: Weekly
    Org Size (# of Employees): 26 - 99
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    Excellent tool for QM

    Updated: Sep 09 2026
    Summary

    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.

    Positive

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

    Negative

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

    Read More...
  • Reviewer Name: A Verified Reviewer
    Position: Engineer
    Has used product for: Less than 6 months
    Uses the product: Monthly
    Org Size (# of Employees): 20,000 or More
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you Recommend to Others?
    1 2 3 4 5 6 7 8 9 10

    Review: GGuru

    Date: Sep 10 2026
    Summary

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

    Positive

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

    Negative

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

    Read More...
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