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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

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Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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Greenlight Guru Quality Pricing

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

Essentials
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Essentials Includes:
  • Check Document Management
  • Check Change Management
  • Check Design Controls (3 Projects)
  • Check Risk Management
  • Check Product Management (BOM)
  • Check Task Management
Plus
All-In-One
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Everything in Essentials with
the addition of:
  • Check Design Controls (Unlimited Projects)
  • Check Training Management
  • Check CAPA Management
  • Check Audit management
  • Check Nonconformance Management
  • Check Complaint Management
  • Check Analytics
  • Check Single Sign On (SSO)
  • Check API
Professional
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Everything in Essentials and Plus with the addition of:
  • Check Single Sign On (SSO)
  • Check Greenlight Guru Academy Advance (20 memberships)
  • Check Enterprise Security & Compliance
Compliant
Guru Services

Enhance your team with an extension of ours.

Our seasoned MedTech Gurus will ensure that you have what you need for your QMS implementation to run smoothly, while also providing clarity around the regulatory process and best practices for managing quality throughout your device's lifecycle.

Receive a dedicated quality and regulatory expert that will provide:
  • Training
  • Quality Assurance
  • Regulatory Compliance
  • Audit Support
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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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Always Included

Dedicated Customer Success Manager
Validation Package with each Product Update
Online Support
On-Demand Academy, Community, and Online help resources, workshops, and more

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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Frequently Asked Questions

Do I need to buy onboarding services?

All new Greenlight Guru customers must buy our quick-start onboarding services to get started on the right foot with your quality management efforts. Quality management 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.

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 probably thinking… 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 that include Bayer, Siemens Healthcare, Under Armour, and even the FDA. Check out our system overview which covers data storage, disaster recovery, and security in order to clarify any outstanding questions regarding security when using the cloud.

What type of support is available to users?

All Greenlight Guru users (regardless of user level or permissions) have access to our Greenlight Guru Help Center for support. The mission of our help center is to get your team up to speed on using the software, study our knowledge base of QMS best practices, and stay up-to-date on the industry.