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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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CUSTOMERS

Your Success is Our Success

We're proud to work with the best MedTech companies in the industry. Don't just take it from us. Explore our customer success stories to learn more about your community.

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1,100+ of the world’s leading MedTech companies trust Greenlight Guru.

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Case Study

PSA Flanders Uses Greenlight Guru Clinical and Gets Exceptionally High Response Rates to their Survey

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Case Study

HTD Health Chooses Greenlight Guru Quality for a Modern, SaMD-Friendly eQMS

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How Creo Medical Streamlined Innovation and Development with Greenlight Guru's QMS Software

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Oticon Medical Continues Striving for Clinical Excellence

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Scaling SaMD Company Switches from Paper to Greenlight Guru’s eQMS Solution and Increases Efficiency While Reducing Costs

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Bernafon’s Clinical Trial Data Management Journey from Excel to Greenlight Guru Clinical

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How Hart Biologicals Cut Audit Prep Time in Half with a Purpose-Built QMS Platform

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World Leader in Regenerating Damaged Human Tissues Uses Greenlight Guru Clinical

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Avenda Health Gets SaMD Product to Market Easier with Greenlight Guru’s Purpose-Built QMS

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Monitored Therapeutics, Inc: Building an Audit-ready QMS in 3 Months

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Tenacore Passes ISO 13485:2016 Recertification Audit with the Help of Greenlight Guru’s Modern Platform

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How a Class III Device Company Passed Their ISO 13485:2016 Re-Certification Audit with a Modern QMS and Industry Expertise

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Clinical Trials on AI-Assessed QTc Measurement Directly from Consumer Smartwatches

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MDR Compliant Prospective & Retrospective Clinical Studies

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European IVD Startup Gets Fast, Accurate Clinical Data with Greenlight Guru's EDC System

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How Puzzle Medical is Putting Together the Pieces for Success with Greenlight Guru

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How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile

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How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical

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How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

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How Delta Development Fast-tracked R&D Down to a Single Year by Implementing a MDQMS

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How Flexlogical Is Making Quality A Competitive Advantage By Adopting Data-driven Approach With MDQMS

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Case Study

C2DX, INC. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)

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Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

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Case Study

Centese Trades in Paper-Based QMS for Medical Device Success Platform & Achieves 510(K) Clearance

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How Innovere Has Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device Specific eQMS

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Lucerno Dynamics Has Simplified the ISO 13485:2016 Certification Process with Greenlight Guru

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How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X In Two Years

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How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

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How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

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How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

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Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru

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The Greenlight Guru Advantage - More Than QMS Software

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LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development

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Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to Greenlight Guru

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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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Partnering with Greenlight Guru provides you with a team that's on your side, who are all medical device industry pros and understand what companies like ours go through.

Morris Sherwood Person Responsible for Regulatory Compliance, Zyris, Inc.
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/Zyris.png play

Partnering with Greenlight Guru provides you with a team that's on your side, who are all medical device industry pros and understand what companies like ours go through.

Morris Sherwood Person Responsible for Regulatory Compliance, Zyris, Inc.
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.

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, achieving excellence has never been easier.

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1100 +

MEDTECH COMPANIES TRUST OUR PLATFORM

1700 +

510(K) CLEARANCES AND CE MARKINGS

$ 125 k

SAVED ON AVERAGE PER PROJECT

2000 +

ISO 13485 CERTIFICATIONS