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A modern eQMS for product-led,
fast-moving medtech innovators.

  • Built to fit your process, not force it
  • Stay focused on product, not paperwork
  • Built for engineers and trusted by auditors

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Greenlight Guru Ultralight today.

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An eQMS for product-led,
fast-moving medtech innovators.

  • Flexible to support how you work
  • Help engineers stay compliant as they build
  • Integrates with your existing tech stack

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An eQMS for established and
expanding medtech teams.

  • Guardrails to guide your team
  • Built for global scale
  • Audit-tested quality workflows

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Data collection and management
designed for medtech clinical trials.

  • No-code setup for any study type
  • A single platform for all your studies
  • Facilitating ISO 14155 and 21CFR Part 11 compliance

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Greenlight Guru Clinical today.

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Solutions
Why Us
Customers
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Company
Resources
BestQMS-book-mockup-01

Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

View Now
Pricing
Contact Sales Get a Demo
Contact Sales
Get a Demo

Greenlight Guru Quality Pricing

Start, scale, and succeed with the world's #1 QMS software purpose-built for medical device companies.

Talk to Sales See Pricing Guide

Your journey begins with Core.

Set the foundation for quality with Core then choose additional packages that align with your organization's goals.

Core
Establish an efficient, compliant quality system that's easy to use and ready to grow with your business.
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Core Includes
  • Check Document Management
  • Check Single Sign On
  • Check Change Management
  • Check Data Exports & APIs
  • Check Training Management

Customize Your QMS Plan

Add on additional functionality and scale your plan to meet your team's needs.

Product Development
Bring safe and effective products
to market faster, more efficiently
and with less risk.
  • Check Design Control
  • Check Risk Management
  • Check Product Management
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Quality Events
Gain a clear overview of your quality activities, ensuring every detail is traceable and managed effectively.
  • Check CAPA
  • Check Audit
  • Check Nonconformance
  • Check Customer Feedback
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Guru Services
Tap into our expert insights and guidance to navigate challenges and achieve your goals at every stage.
  • Check In-App Support
  • Check Dedicated Industry Expert
  • Check Project/Custom Services
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Always Included

Dedicated Customer Success Manager

Onboarding and Implementation Guru

Validation Package with Every Product Update

Online Support

On-Demand Training

Collage
QMS Templates

Get started with the right documentation.

These audit-tested procedures, work instructions, and forms will streamline the implementation of your quality management system and save you time during implementation and audits. 

Receive these audit-tested templates for your QMS:
  • Quality Manual
  • Management Review Template
  • Project and Risk Plans
  • Supplier Survey Forms
  • Quality Event Procedures and Templates
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Daniel Powell

Greenlight Guru’s software is expensive on day one, and dirt cheap on day two. This is a year’s worth of someone’s salary already done, implemented, and ready to go.

Daniel Powell

CEO | Spark Biomedical

Frequently Asked Questions

Why do all packages require a Core subscription?

Core ensures that your QMS has the best foundation to succeed. With our Core package, you'll be able to connect your team, processes, and quality data into one single source of truth for your quality management needs. From there, you can choose one or more of our add-ons to fit a solution best for your business.

Do I have to buy onboarding services?

All new Greenlight Guru customers must purchase our one-time onboarding services to get started. Implementing an eQMS is about more than just staying in compliance; it’s about using quality as your competitive advantage. Our team makes that easy for you by guiding you through the software training and implementation with the support of our passionate Customer Success team and industry Gurus.

What type of support is available to users?

All Greenlight Guru users have access to our Greenlight Guru Help Center for support and the Greenlight Guru Academy for on-demand, Guru-led training courses.

We want to get your team up to speed on using the software at your pace with access to our extensive knowledge base of QMS how-to’s and best practices to get the most out of your subscription and experience with our solutions. 

How is the software deployed?

Similar to many modern Software as a Service (SaaS) platforms, like Customer Relationship Management (CRM) and Enterprise Resource Planning (ERP) platforms, Greenlight Guru is a cloud-based software offered on a subscription basis that can be securely accessed anywhere via standard web browsers.

You’re next question may be… Is my organization’s data and information safe in the cloud? Yes — it is! Greenlight Guru's software is hosted on Amazon Web Services, which is the hosting service of choice for many Fortune 100 companies including Bayer, Siemens Healthcare, Under Armour, and even the FDA. Check out our system overview which covers data storage, disaster recovery, and security to clarify any outstanding questions regarding security when using the cloud.

Is there an additional charge for Greenlight Guru’s Validation Package?

No there is not. We recognize that software validation can be a daunting and time-consuming task for MedTech companies, regardless of their resources. Therefore, we have assumed this responsibility to offer a superior experience and essential resources. This ensures your team meets the dynamic validation requirements efficiently, allowing you to dedicate more time to utilizing the software and minimizing time spent on testing it.

For more information on our Validation Package, visit here.

Are You Ready to Experience the Greenlight Guru Difference?

With solutions to improve every stage of your product lifecycle and a team excited to support you, reaching success has never been easier.

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