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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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Greenlight Guru for Executives

Achieve peace of mind knowing your quality system can stay ahead of compliance changes. Be confident your team has the best MedTech partner in Greenlight Guru. We help you fill execution gaps, connect your teams and processes, and, yes, even please the FDA.

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Creating Innovative Products is a Constantly Evolving Challenge

You and your team work hard to design and deliver innovative, life-changing medical technologies to market. From managing lengthy and changing regulatory approval processes to fielding funding concerns to dealing with market competition — navigating the process can be tricky. To succeed, your team needs to seamlessly connect many disciplines, processes, people, and datasets while operating within an ever-changing regulatory and compliance environment — that’s where Greenlight Guru comes in. As the only platform created and dedicated to MedTech Lifecycle Excellence, Greenlight Guru helps close some of the execution gaps standing between you and unparalleled success.

Why Executives Love
Greenlight Guru

Ecosystem of Support
Tailored Solutions
Grow Faster
Demystify the Complex
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Holistic solutions for team enablement

Our guidance isn’t limited to a siloed solution focussed on a single part of your production process. We include an ecosystem of resources to enable your team and provide critical end-to-end support for your organization.

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Don’t settle for one-size-fits-all offerings

Our solution is tailor-made for the MedTech industry, offering a purpose-built solution for any stage of the commercialization journey, from ideation to development to postmarket surveillance.

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Accelerate product development

Get your products to market quicker while maximizing the efficiency of your resources. Grow faster with a quality system that allows you to scale and navigate international markets.

Streamline Product Development
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Enjoy the simple things in life

We take complicated production cycles and simplify them. Our platform and community provide your team the necessary resources to build the highest quality processes throughout your entire product lifecycle.

Why Switch

1,000+ of the world’s leading MedTech companies trust Greenlight Guru.

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.

Proactively Identify and Reduce Risk With Greenlight Guru

Empower your team with a software platform that accelerates device clearance timelines and helps reduce risks.

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1000 +

MedTech companies trust our platform

$ 125 K

saved on average per project

3

months faster to market

402

hours saved on low value-added activities