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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.

What is BrightInsight?

BrightInsight simplifies the journey for clients aiming to introduce their digital health innovations to the market, which includes a variety of offerings such as apps, algorithms, medical devices, integrated combination products, diagnostics, and Software as a Medical Device (SaMD) across multiple therapeutic fields. By removing the need for time-consuming and intricate custom implementations, BrightInsight delivers a ready-to-use, validated digital health platform designed within a Quality Management System that adheres to international standards for security, privacy, and regulatory compliance. For example, we supported Roche in launching a SaMD dosing calculator for hemophilia A in Europe within just six months, and we hastened the development of a remote patient platform for a Top 10 Biopharma company, taking it from concept to market readiness in under a year. Our proficiency is rooted in creating and managing regulated digital health products within the biopharma and medtech sectors, with several successful commercial launches achieved over the past year alone. With unwavering dedication to innovation and excellence, we consistently position ourselves at the forefront of the industry, delivering impactful digital health solutions that cater to evolving healthcare needs. As we advance, our focus remains on enhancing patient outcomes through cutting-edge technologies and partnerships.

Media

Media

Integrations Supported

GitHub
Google Drive
Jira
Microsoft 365

Integrations Supported

GitHub
Google Drive
Jira
Microsoft 365

API Availability

Has API

API Availability

Has API

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.
Free Version
Free Trial Offered?

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Greenlight Guru

Date Founded

2013

Company Location

United States

Company Website

greenlight.guru

Company Facts

Organization Name

BrightInsight

Date Founded

2017

Company Location

United States

Company Website

brightinsight.com

Categories and 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

Categories and Features

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Healthcare CRM

Audience Targeting
Campaign Management
Marketing Automation
Medical History Records
Patient Communications
Patient Management
Physician Management
Predictive Analytics

IoT

Application Development
Big Data Analytics
Configuration Management
Connectivity Management
Data Collection
Data Management
Device Management
Performance Management
Prototyping
Visualization

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