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Greenlight Guru QMS

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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SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

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Featured Capabilities:

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

Get a personalized demo of SMART-TRIAL by Greenlight Guru today.

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Greenlight Guru Academy

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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Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

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Guru Advisory Services

Enhance Your Team With Ours

Navigate each stage of your commercialization journey and stay on track to achieve MedTech Lifecycle Excellence with dedicated expertise at your fingertips.

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Explore All Guru Services

Direction, innovation, and guidance at every stage in your commercialization journey. Partner with our Gurus who help you efficiently navigate medical device regulations, reduce risk, and prepare for successful launch and audits.

Advisory Services
Guru Assist
Guru Strategy Sessions
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Get Strategic Guru Advising

Gain clarity around regulatory requirements and leverage industry best practices to confidently meet your objectives at each stage of your medical device journey.

Benefits: 
  • Meet regularly in focused 1-hour sessions
  • Customized plan designed to meet your needs
  • Support mission-critical processes
  • Library of SOPs with regular updates
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Get Real-Time Support

Save time with an industry sounding board on best practices right when you need it, and expedited software support.

Benefits:
  • On-demand assistance and coaching
  • Easy, in-app functionality
  • Expedited software support
  • Library of SOPs with regular updates
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Strategize With A Guru On Specific Topics

Strategic Guru session topics include:
  • Quality system design recommendations
  • Quality documentation review
  • Design control best practices
  • DHF / Technical File evaluation
  • Risk management structures
  • Product submission review
  • CAPA & Complaint definition
  • Regulatory strategy and planning
  • Quality event support
  • Audit preparation and practice

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 services from onboarding to ongoing assistance in everything from how to use our software to best practices in audit preparation.
Dedicated Customer Success Managers

Gain clarity around regulatory requirements and leverage industry best practices to confidently meet your objectives at each stage of your medical device journey.
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.
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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
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 MedTech Lifecycle Excellence. There are no limits to the potential you hold—now it's up to you to take the first step.

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