---
description: Review of Greenlight Guru Software: system overview, features, price and cost information. Get free demos and compare to similar programs on Software Advice New Zealand.
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title: Greenlight Guru | Reviews, Pricing & Demos - SoftwareAdvice NZ
---

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# Greenlight Guru

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> Greenlight Guru is the \#1 quality management system built exclusively for medical device companies. Not life sciences. Not pharma with a medtech configuration layer. Because we built exclusively for medical devices, ISO 13485, ISO 14971, and FDA QMSR aren't frameworks you configure after the fact. They're the foundation.

Most quality teams manage compliance across systems that were never designed to talk to each other. A document control tool here, a spreadsheet for CAPAs there, a separate process for change control. In a regulated environment, that gap doesn't stay invisible, it shows up during audits. Greenlight Guru gives Quality and Product teams a single connected system where document control, training, CAPA, nonconformance, change control, supplier management, risk management, and design controls work together. When a change happens, it flows through the workflow. Meaning limited manual handoffs, and nothing falling through the cracks between teams.

For Quality and Regulatory Affairs professionals, that means audit-ready workflows with automated routing, electronic signatures, and complete audit trails built in, including end-to-end traceability across design controls. No more chasing approvals or manually tracking compliance status. Teams that run on Greenlight Guru are 3.5x less likely to receive a major audit finding. 

For R\&D and product teams, it means staying in the tools they already use, with changes automatically syncing to design controls so documentation builds itself as you work, not after the fact as a separate project.

Greenlight Guru AI handles the repetitive work that slows teams down, and it was built with 15 years of medtech context behind it, not bolted on from a general-purpose model. AI-powered search finds answers across your QMS instantly. Chat analyzes system data to surface insights. Auto-generated summaries give immediate context on documents, suppliers, and quality events. For product teams, verifiability checks catch vague requirements before they become audit findings, suggested links close traceability gaps automatically, and AI brainstorming gets engineers moving faster. For quality teams, AI generates training quizzes and drafts change order summaries, so your team spends less time writing and more time on the work that actually requires their expertise.

The platform is validated out of the box and aligned to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR Part 11. Implementation is measured in weeks, not the quarters-long projects that come with legacy enterprise platforms. Backed by 80+ audit-tested, customizable templates and a team of experts who know medtech inside and out. You're not managing a separate validation project before you can go live.

For 15 years and across more than 1,000 device companies worldwide, Greenlight Guru has been the QMS medical device teams trust to pass audits, bring products to market, and stay on the market longer.
> 
> Verdict: Rated **4.4/5** by 80 users. Top-rated for **Likelihood to recommend**.

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## Quick Stats & Ratings

| Metric | Rating | Detail |
| **Overall** | **4.4/5** | 80 Reviews |
| Ease of Use | 4.2/5 | Based on overall reviews |
| Customer Support | 4.6/5 | Based on overall reviews |
| Value for Money | 4.3/5 | Based on overall reviews |
| Features | 4.2/5 | Based on overall reviews |
| Recommendation percentage | 80% | (8/10 Likelihood to recommend) |

## About the vendor

- **Company**: Greenlight Guru
- **Location**: Indianapolis, US
- **Founded**: 2013

## Commercial Context

- **Pricing model**: Other
- **Pricing Details**: Contact Greenlight Guru for pricing details.
- **Target Audience**: Self Employed, 2–10, 11–50, 51–200, 201–500
- **Deployment & Platforms**: Cloud, SaaS, Web-based
- **Supported Languages**: English
- **Available Countries**: Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Latvia, Liechtenstein and 17 more

## Features

- API
- Access Controls/Permissions
- Activity Dashboard
- Activity Tracking
- Alerts/Escalation
- Alerts/Notifications
- Approval Process Control
- Audit Management
- Audit Trail
- Change Management
- Communications Management
- Complaint Management
- Compliance Management
- Corrective and Preventive Actions (CAPA)
- Data Import/Export
- Data Visualisation
- Defect Tracking
- Document Coding & Control
- Document Management
- Document Review

## Integrations (4 total)

- GitHub
- Google Drive
- Jira
- Microsoft 365

## Support Options

- Email/Help Desk
- FAQs/Forum
- Knowledge Base
- Chat

## Category

- [Corrective and Preventive Action Software](https://www.softwareadvice.co.nz/directory/4713/capa/software)

## Related Categories

- [Corrective and Preventive Action Software](https://www.softwareadvice.co.nz/directory/4713/capa/software)
- [Quality Management Software](https://www.softwareadvice.co.nz/directory/420/quality-management-software/software)

## Alternatives

1. [MasterControl Quality Excellence](https://www.softwareadvice.co.nz/software/142000/mastercontrol) — 4.5/5 (539 reviews)
2. [Isolocity](https://www.softwareadvice.co.nz/software/79422/isolocity) — 4.6/5 (66 reviews)
3. [KAWAK](https://www.softwareadvice.co.nz/software/357377/kawak) — 4.6/5 (343 reviews)
4. [Qualio](https://www.softwareadvice.co.nz/software/152557/qualio) — 4.6/5 (138 reviews)
5. [Dot Compliance](https://www.softwareadvice.co.nz/software/239986/dot-compliance) — 4.4/5 (94 reviews)

## Reviews

### "Best software for medical purposes" — 5.0/5

> **Alfikhar** | *24 January 2025* | Civil Engineering | Recommendation rating: 10.0/10
> 
> **Pros**: Industry specific,compliance focus,collaboration
> 
> **Cons**: Limited customization,cost,complexity tp use
> 
> Greenlight Guru is a powerful QMS solution that can be a valuable asset for medical device companies seeking to improve quality, efficiency, and compliance.

-----

### "Collectively" — 5.0/5

> **Jeroen van** | *5 February 2025* | Information Technology & Services | Recommendation rating: 10.0/10
> 
> **Pros**: It helps much to the new users in collective management
> 
> **Cons**: I haven't got any problem with this software
> 
> It is a user-friendly interface and best for the new users

-----

### "GreenLight is the best product development software" — 5.0/5

> **Kevin** | *2 August 2019* | Biotechnology | Recommendation rating: 10.0/10
> 
> **Pros**: GreenLight team members are very responsive to concerns. The software itself is essential for any small-medium company hoping to get through the product development process and receive FDA clearance/approval.
> 
> **Cons**: I wish there was a training module. Training currently uses up a good amount of our time.

-----

### "Supercool Medical Software" — 5.0/5

> **Yusuf** | *9 February 2025* | Health, Wellness & Fitness | Recommendation rating: 10.0/10
> 
> **Pros**: What I like most about Greenlight Guru is that its made to help the medical industries all over the world.
> 
> **Cons**: What i like least about Greenlight Guru is that its not well known and need s to be advertised more.
> 
> My overall experience with Greenlight Guru is that its made to meke medical software more efficient, faster, \& more great benefits.

-----

### "Great compliance tool for medical device companies" — 5.0/5

> **Jordan** | *16 February 2025* | Alternative Medicine | Recommendation rating: 10.0/10
> 
> **Pros**: Greenlight Guru offers a user-friendly interface and great compliance management tools. It helps streamline document control, risk management, and audits, making regulatory compliance much easier.
> 
> **Cons**: The platform can be a bit expensive for smaller teams, and the learning curve for new users might take some time.
> 
> Greenlight Guru has been a valuable tool for managing quality processes efficiently. It simplifies regulatory compliance and improves collaboration across teams. While the price may be high, the benefits outweigh the cost for companies focused on medical device compliance.

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## Links

- [View on SoftwareAdvice](https://www.softwareadvice.co.nz/software/429041/greenlight-guru)

## This page is available in the following languages

| Locale | URL |
| en | <https://www.softwareadvice.com/capa/greenlight-guru-profile/> |
| en-AU | <https://www.softwareadvice.com.au/software/429041/greenlight-guru> |
| en-GB | <https://www.softwareadvice.co.uk/software/429041/greenlight-guru> |
| en-IE | <https://www.softwareadvice.ie/software/429041/greenlight-guru> |
| en-NZ | <https://www.softwareadvice.co.nz/software/429041/greenlight-guru> |

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