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Greenlight Guru

Greenlight Guru

Overview

What is Greenlight Guru?

Greenlight Guru is a quality management platform designed specifically for medical device companies.The platform is designed to help companies get safer products to market faster, simplify FDA and ISO regulatory compliance, and provide a single source of truth by connecting…

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Awards

Products that are considered exceptional by their customers based on a variety of criteria win TrustRadius awards. Learn more about the types of TrustRadius awards to make the best purchase decision. More about TrustRadius Awards

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Pricing

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What is Greenlight Guru?

Greenlight Guru is a quality management platform designed specifically for medical device companies. The platform is designed to help companies get safer products to market faster, simplify FDA and ISO regulatory compliance, and provide a single source of truth by connecting…

Entry-level set up fee?

  • No setup fee

Offerings

  • Free Trial
  • Free/Freemium Version
  • Premium Consulting/Integration Services

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Product Details

What is Greenlight Guru?

Greenlight Guru is a quality management platform designed specifically for medical device companies.

The platform is designed to help companies get safer products to market faster, simplify FDA and ISO regulatory compliance, and provide a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control and more.

The vendor invites device makers across the globe to replace outdated paper-based and general-purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and achieve True Quality. A personalized demo is available at http://www.greenlight.guru

Greenlight Guru Features

  • Supported: Design Controls
  • Supported: Risk Management
  • Supported: Audit Management
  • Supported: Document Control
  • Supported: Quality Processes (CAPA, Nonconformance, Customer Feedback)
  • Supported: Analytics & Reporting

Greenlight Guru Screenshots

Screenshot of Design Control Spotlight: 
Documenting and managing Design Control traceability has never been easier. Perform Digital Design Reviews through flexible workflows to demonstrate compliance.Screenshot of Document Management Spotlight: 
Speed up reviews and approval workflows by keeping your records and procedures organized, up-to-date, and always accessible to the right people with role-based security.Screenshot of Risk Management Spotlight: 
Integrate Risk Management into all of your quality processes in a system that directly aligns with ISO 14971:2016.Screenshot of Post-Market Quality Events Spotlight:
Streamline your Post-Market Quality Activities to maintain full closed-loop traceability within your QMS.

Greenlight Guru Video

Greenlight Guru Integrations

Greenlight Guru Competitors

Greenlight Guru Technical Details

Deployment TypesSoftware as a Service (SaaS), Cloud, or Web-Based
Operating SystemsUnspecified
Mobile ApplicationNo
Supported LanguagesEnglish
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Comparisons

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Reviews and Ratings

(17)

Attribute Ratings

Reviews

(1-15 of 15)
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Score 9 out of 10
Vetted Review
Verified User
Incentivized
  • Out-of-the-box validated workspace
  • Efficient work flows for documenting quality events and their investigations
  • Efficient work flows for documenting risk management and DHFs
  • Ability to approve documents electronically while remaining in compliance with the FDA's regulations for electronic signatures
  • Ability to store and update important quality documents, and have all employees have access and ability to self-train and document this training
  • On-demand customer service when issues are encountered
Score 9 out of 10
Vetted Review
Verified User
Incentivized
  • Simple user interface that makes it easy for all team members to navigate and collaborate.
  • Proven compliance with FDA and EU regulatory standards.
  • Cloud based system that makes document management easy.
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