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

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management Supplier 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 Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

Get a personalized demo of Greenlight Guru Clinical today.

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Solutions
Why Us
Customers
Partners
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Resources
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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.

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Guru Advisory Services

Enhance Your Team With Ours

Leverage our 500+ years of combined medical device industry experience to confidently meet your objectives at every stage of your commercialization journey.

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Guru Services

Partner with our medical device experts as they help you efficiently navigate medical device regulations, reduce risk, and prepare for successful launch and post-market activities.

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Guru Assist

  On-demand assistance and coaching from industry experts

  Easy, in-app functionality

  Expedited software support

Guru Guidance

 Strategically scheduled calls with industry expert

 Actionable coaching and support

 Journey checklist and resources provided by stage

Professional Services

 System Configuration & Implementation

 Design Control & Risk Review

 Process Automation

 Audit Preparation

 And much more...

Templates

 Quality Manual

 Management Review Template

 Project and Risk Plans

 Clinical Evaluation Templates

 Clinical Anomaly Templates

 And many more...

We Bring Deep Expertise in the MedTech and Medical Device Industry

500 +

years of industry experience

300 +

companies in our partner network

16

quarters rated a leader in G2 Medical QMS

97 %

users ranked our quality of support at 97%
loopMark

How We Set You Up for Success

Guru Advisory Services

Engage with industry professionals that provide a range of quality management services from onboarding to ongoing assistance in everything from how to use our software to best practices in audit preparation.

Dedicated Customer Success Managers

Stay on track to achieve key milestones with dedicated customer success manager at your fingertips.

Customer Support

Whenever you may come across a roadblock, your Gurus are ready to help. Providing fanatical support is something we strive for in everything we do, so when you need us, we’re here for you.

Academy

Accelerate your learning and proficiency - both in Greenlight Guru solutions and industry practices. You’ll be equipped to build key competencies for your teams.
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Guru SOP Template Library

Streamline the Setup of Your Quality Management System

We've created 70+ audit-tested procedures, work instructions, and forms to save you time during implementation and put your team at ease during audits.

Our audit-tested QMS templates include:
  • Quality Manual
  • Management Review Template
  • Project and Risk Plans
  • Clinical Evaluation Templates
  • Quality Event Procedures and Templates
  • Supplier Survey Forms

Built for Customers Like You

Establishing a QMS
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Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission.

Ryan Nolan Co-Founder / VP of Clinical Operations Photonicare
Culture of Quality
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Greenlight Guru was instrumental in implementing our Quality System. With them, we can bring safer, higher-quality medical devices to success while maintaining a Quality Culture throughout our entire device lifecycle.

Maxime Rochan Director of Quality Puzzle Medical
Impress Auditors
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Greenlight Guru has differentiated us from other start-ups. Our auditors told us, "Wow, you're steps ahead of anyone else."

Amy Papranec VP of Clinical Operations Critical Care Diagnostics, Inc.
https://blog.greenlight.guru/hubfs/GG22_theme-files/accents_graphics_textures_etc/testimonial-slider/testimonialSlider_default-image_rs.jpg play

Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission.

Ryan Nolan Co-Founder / VP of Clinical Operations Photonicare
https://blog.greenlight.guru/hubfs/Puzzle_Med-875x530-1.jpg play

Greenlight Guru was instrumental in implementing our Quality System. With them, we can bring safer, higher-quality medical devices to success while maintaining a Quality Culture throughout our entire device lifecycle.

Maxime Rochan Director of Quality Puzzle Medical
https://blog.greenlight.guru/hubfs/C2Dx-875x530-2.jpg play

Greenlight Guru has differentiated us from other start-ups. Our auditors told us, "Wow, you're steps ahead of anyone else."

Amy Papranec VP of Clinical Operations Critical Care Diagnostics, Inc.

Discover What's Possible With Guru Advisory Services

With our democratized model of sharing industry expertise and best practices, you’ll be set to blaze new trails on your way to success.

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