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.

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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

See Integrations

Ratings/Reviews - 3 User Reviews

Overall 4.3 / 5
ease 4.3 / 5
features 4.0 / 5
design 4.0 / 5
support 3.7 / 5
More Reviews Write a Review

Company Information

Greenlight Guru
Founded: 2013
United States
greenlight.guru

Videos and Screen Captures

Design Control Software

Design Control Software

Design Control Software Advanced Document Management Quality Events Management (CAPA, Audit, Nonconformance, Complaints) Risk Management Software
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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

Greenlight Guru Verified User Reviews

Write a Review
  • 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...
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