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About

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.

About

Are you looking for recognized and innovative methods to improve the management, productivity, performance and profitability of your organization? Document your problems, analyze them and provide concrete and sustainable solutions in a systematic way in order to be even more efficient and have a better performance. This is what we offer you with our structured, customizable and integrated software solutions. Effectively and optimally take charge of all operational excellence, quality, compliance and continuous improvement management activities according to the recognized "Plan - Do - Check - Act (PDCA)" approach. For over 20 years, IsoVision has been working closely with its clients to bring new modules and new features in order to make the software correspond. Thus, throughout the year, we always prioritize our clients’ requests and integrate them to the software as new updates.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

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

Audience

Companies seeking a solution to manage and improve their operations

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

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.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 4.4 / 5
ease 4.4 / 5
features 4.2 / 5
design 3.8 / 5
support 4.0 / 5

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Pros & Cons from Real Users

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

  • There can be a lot of notifications, and some pages are slower than others.
  • 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.
  • Occasionally, the login or password reset process could be smoother. Improving that experience would make the platform even easier to use.
  • The controls may take a little time to get used to.
  • Honestly, there isn't much I didn't like. It works well!

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Greenlight Guru
Founded: 2013
United States
greenlight.guru

Company Information

IsoVision
Founded: 2000
Canada
www.isovision.com

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GainSeeker Suite

Hertzler Systems
Greenlight Guru Clinical

Greenlight Guru Clinical

Greenlight Guru
Trevally

Trevally

ManualMaster

Categories

Categories

Quality Management Features

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

Quality Management Features

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

Integrations

GitHub
Google Drive
Jira
Microsoft 365

Integrations

GitHub
Google Drive
Jira
Microsoft 365
Claim Greenlight Guru and update features and information
Claim Greenlight Guru and update features and information
Claim IsoVision and update features and information
Claim IsoVision and update features and information