Greenlight Guru Description

Over 1,000 medical device manufacturers rely on Greenlight Guru, a quality management system purpose-built for medtech. The platform is designed around the regulatory environment your industry operates in, 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 configured later.

Implementation takes weeks, not quarters. With 80+ audit-tested templates and medtech-expert support, you avoid the lengthy validation project and launch faster.

Greenlight Guru uses AI-powered automation to eliminate manual administrative work while preserving the audit trail and documentation standards your compliance requires.

With 15 years in medical device quality systems, Greenlight Guru helps you pass audits, get to market faster, and sustain long-term success.

Pricing

Pricing Information:
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

Reviews - 10 Verified Reviews

Total
ease
features
design
support

Company Details

Company:
Greenlight Guru
Year Founded:
2013
Headquarters:
United States
Website:
greenlight.guru
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Product Details

Platforms
Web-Based
Types of Training
Training Docs
Live Training (Online)
Webinars
Customer Support
Business Hours
Live Rep (24/7)
Online Support

Greenlight Guru Features and Options

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

Greenlight Guru Lists

Greenlight Guru User Reviews

Write a Review
  • Name: Anonymous (Verified)
    Job Title: Engineer
    Length of product use: Less than 6 months
    Used How Often?: Monthly
    Role: User
    Organization Size: 20,000 or More
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to 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 A bit outdated when it comes to AI technology.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...
  • Name: Anonymous (Verified)
    Job Title: QA
    Length of product use: Less than 6 months
    Used How Often?: Monthly
    Role: User
    Organization Size: 1,000 - 4,999
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    It was good

    Edited: 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...
  • Name: Dipali T.
    Job Title: Quality Engineer
    Length of product use: Less than 6 months
    Used How Often?: Weekly
    Role: User
    Organization Size: 1,000 - 4,999
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to 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...
  • Name: Anonymous (Verified)
    Job Title: MDT
    Length of product use: Less than 6 months
    Used How Often?: Weekly
    Role: User
    Organization Size: 26 - 99
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to 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...
  • Name: Anonymous (Verified)
    Job Title: Senior Engineer
    Length of product use: 6-12 Months
    Used How Often?: Weekly
    Role: User
    Organization Size: 1 - 25
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to 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...
  • Name: Anonymous (Verified)
    Job Title: Project Manager
    Length of product use: Less than 6 months
    Used How Often?: Monthly
    Role: User
    Organization Size: 5,000 - 9,999
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to 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...
  • Name: Anonymous (Verified)
    Job Title: Clinical Research Associate
    Length of product use: 6-12 Months
    Used How Often?: Weekly
    Role: User
    Organization Size: 26 - 99
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    Excellent tool for QM

    Edited: 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...
  • Name: Anonymous (Verified)
    Job Title: Recruiting Coordinator
    Length of product use: 6-12 Months
    Used How Often?: Yearly
    Role: User
    Organization Size: 100 - 499
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to 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...
  • Name: Celine L.
    Job Title: Service marketing manager
    Length of product use: 6-12 Months
    Used How Often?: Monthly
    Role: User
    Organization Size: 20,000 or More
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to 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...
  • Name: Anonymous (Verified)
    Job Title: Senior manager
    Length of product use: Less than 6 months
    Used How Often?: Weekly
    Role: User
    Organization Size: 1 - 25
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to 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...
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