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About

BrightInsight accelerates time to market for our customers’ digital health products, including apps, algorithms, medical devices, connected combination products, diagnostics, and Software as a Medical Device (SaMD) across therapeutic areas. BrightInsight replaces the need for lengthy and complicated ‘build from scratch’ implementations and instead offers a pre-built and proven digital health platform designed under a Quality Management System to support global security, privacy, and regulatory requirements. We helped Roche launch a Software as a Medical Device (SaMD) dosing calculator for hemophilia A in 6 months in Europe, and accelerated a Top 10 Biopharma companies remote patient platform from project kickoff to commercialization in less than a year. We are experts at building and maintaining biopharma and medtech regulated digital health products, with multiple commercial launches in the last year alone.

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.

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

Global IoT platform for biopharma and medtech companies

Audience

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

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

No information available.
Free Version
Free Trial

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

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:

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Reviews/Ratings

Overall 4.4 / 5
ease 4.5 / 5
features 4.6 / 5
design 4.3 / 5
support 4.3 / 5

Pros & Cons from Real Users

Pros

  • Easy UI. Great theme; professional. Very well structured. Easy to navigate. Great reminder feature.
  • Very helpful, easy to use, valuable experience, and definitely worth the investment. Helpful, useful, easy to use, and worth the investment.
  • Greenlight Guru takes a lot of the manual stress out of maintaining a DHF and QMS, and it makes audits noticeably easier to prepare for and get through. The structure it enforces around documentation is genuinely useful, especially compared to more ad hoc systems.
  • Purpose-built for medical device companies, with workflows aligned to industry regulations and standards. Strong document control and traceability, making it easier to manage audits and maintain compliance records. Centralized platform for quality management, training, CAPA management, audits, and risk processes. User-friendly interface that helps teams find information quickly and manage activities from a single dashboard. Good visibility and reporting, helping organizations stay audit-ready and monitor quality activities efficiently. Scalable solution that can grow alongside an organization's quality and compliance requirements.
  • I like the usability of this platform, which makes it easy for me to find relevant documents with search functions.

Cons

  • Would love an AI summary feature to quickly summarize long documents when feasible
  • No major issues found so far; overall experience has been positive and satisfying.No major issues experienced so far.
  • As someone who joined a company with an already well-established QMS in Greenlight Guru, I found the sheer volume of files a bit daunting to navigate at first. The system relies heavily on filters and groupings that someone else has already set up, so if you don't already know what you're looking for, it can be hard to find your way around. A more traditional tiered/folder-style view would have made it much easier to explore and orient myself, especially as a newer user.
  • Initial implementation and configuration can require time and planning, particularly for organizations migrating from paper-based or legacy systems. Training is needed to fully utilize all features, especially for less frequent users. Pricing may be a consideration for smaller organizations or start-ups, depending on budget constraints. Some advanced processes and workflows may feel complex until users become familiar with the platform.
  • There are times when there are too many buttons to push to complete a task, for example, when completing training.

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

BrightInsight
Founded: 2017
United States
brightinsight.com

Company Information

Greenlight Guru
Founded: 2013
United States
greenlight.guru

Alternatives

Alternatives

AlphaMED

AlphaMED

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Propel

Propel

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Jama Connect

Jama Connect

Jama Software
Altis Labs Nota

Altis Labs Nota

Altis Labs
Greenlight Guru Clinical

Greenlight Guru Clinical

Greenlight Guru

Categories

Categories

Compliance Features

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

Healthcare CRM Features

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

IoT Features

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

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
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