Average Ratings 3 Ratings

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ease
features
design
support

Average Ratings 0 Ratings

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ease
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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.

Description

ins2outs is an advanced cloud-based SaaS platform designed for integrated compliance management, enabling organizations to establish, implement, and sustain various management systems such as quality, information security, privacy, environment, and AI within a cohesive framework. By merging robust software with pre-configured "know-how" sets aligned to standards like ISO 13485/21 CFR 820, ISO 27001, ISO 27701, IEC 62304, and ISO 42001, along with expert consulting services, it empowers organizations to create organized documentation—comprising policies, processes, procedures, instructions, and document templates. Additionally, it facilitates workflow management through automated role-based training, timely push notifications, compliance KPIs, customizable documentation logic, version control, and detailed audit trails, all securely hosted in the cloud. Users benefit from the ability to operate interconnected systems that fulfill various regulatory and standard obligations, while collaboratively managing electronic documentation with built-in traceability and export capabilities. This comprehensive approach not only enhances compliance but also streamlines operational efficiency across different regulatory environments.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

GitHub
GitLab
Google Drive
Jira
Microsoft 365
Microsoft Teams
OpenAI
Slack

Integrations

GitHub
GitLab
Google Drive
Jira
Microsoft 365
Microsoft Teams
OpenAI
Slack

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.
Free Trial
Free Version

Pricing Details

$25 per month
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Greenlight Guru

Founded

2013

Country

United States

Website

greenlight.guru

Vendor Details

Company Name

ins2outs

Country

Poland

Website

ins2outs.com

Product Features

Quality Management

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

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