qmsWrapper Reviews & Ratings

qmsWrapper

4.7 out of 5 stars
Greenlight Guru Reviews & Ratings

Greenlight Guru

4.4 out of 5 stars

Ratings and Reviews 11 Ratings

Total 4.5 out of 5 stars
ease 4.5 out of 5 stars
features 4.5 out of 5 stars
design 4 out of 5 stars
support 5 out of 5 stars

Ratings and Reviews 14 Ratings

Total 4.5 out of 5 stars
ease 4.5 out of 5 stars
features 4.5 out of 5 stars
design 4.5 out of 5 stars
support 4.5 out of 5 stars

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What is qmsWrapper?

qmsWrapper is a connected Quality Management System (eQMS) designed specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, companies can start with Foundation and expand to Lifecycle and Vigilance as their quality system matures. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects document control, training, CAPA, quality events, risk management, technical documentation, supplier quality, and traceability in one platform. AI assists users with quality processes while every action remains human-controlled and fully auditable. Start where the need is greatest. Keep everything you build. Grow your QMS without rebuilding or migrating to another system.

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.

Media

Media

Integrations Supported

Jira

Integrations Supported

Jira
GitHub
Google Drive
Microsoft 365

API Availability

API Availability

Pricing Information

€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Trial Offered?

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.

Supported Platforms

SaaS
Windows
Mac
Linux

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
Webinars
Online Training

Company Facts

Organization Name

qmsWrapper

Company Location

Canada

Company Website

www.qmswrapper.com

Company Facts

Organization Name

Greenlight Guru

Date Founded

2013

Company Location

United States

Company Website

greenlight.guru

Categories and Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Quality Management

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

Categories and 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

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