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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

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 Product Add-Ons

Get a personalized demo of Greenlight Guru Clinical today.

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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.

View Now
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Why Switch?

Are you stuck between disconnected solutions? From manual processes to lost data to time-intensive systems configurations to meet the needs of both your team and auditors, juggling it can be a precarious balancing act. Make the seamless transition to Greenlight Guru and put your mind at rest. You'll take comfort in knowing there's a
solution that fills the gaps.

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The Greenlight Guru Impact

See the Difference for Yourself

In a dynamic industry, generic solutions don't work. It's time to find the right fit for your business with Greenlight Guru.
Calculate Your ROI

The Old Way

Document-centric paper solutions.
Collaboration enabled
Easy to get started
Simple to use
System scalability
Data-driven quality approach
Integrated FDA & ISO best practices
Purpose-built workflows for MedTech
Closed-loop traceability assured
Adherence to standards and regulations
Industry expertise & support
AI / ML for industry processes
The Greenlight Guru Impact

See the Difference for Yourself

In a dynamic industry, generic solutions don't work. It's time to find the right fit for your business with Greenlight Guru.
Calculate Your ROI

Almost There
(But Not Quite)

General product development and QMS tools.
Collaboration enabled
Simple to use
System scalability
Data-driven quality approach
Easy to implement
AI / ML for industry processes
Quality control and assurance
Purpose-built workflows for MedTech
Closed-loop traceability assured
Adherence to standards and regulations
Industry expertise & support
Validation out-of-the-box

The Greenlight
Guru Way

Your purpose-built MedTech Suite.
Collaboration enabled
Easy to implement
Simple to use
System scalability
Data-driven quality approach
AI / ML for industry processes
Quality control and assurance
Purpose-built workflows for MedTech
Closed-loop traceability assured
Adherence to standards and regulations
Industry expertise & support
Validation out-of-the-box
loopMark

Solutions Built With You in Mind

Everything we do enables your success. From streamlining processes to helping companies meet regulatory challenges to best practice guidance, our solutions are built with you in mind. We prioritize regulatory strategies for medical devices to make MedTech companies more successful. We're ready to take your company to the next level. Are you?

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1,100+ 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.

Why MedTech Teams Love Greenlight Guru

System Migration Support Discover More
Regulatory Submissions Preparation Get Started
Product Development Management Enhance Development
Audit Readiness Inject Work With Quality
Postmarket Quality Management Continuous Success

Working With an Established, Trusted Partner

Have you ever wondered what it's like to work with a partner you trust implicitly?
We'll let our customers' success speak for us.

Clearance With Ease
Certification Assurance
Pass Audits with Ease
Expertise Shaped by Experience
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Eliminate unnecessary go-to-market stress

This isn't our first time around the block. With 1700+ 510(k) clearances and CE marked devices under our belt, we'll put your mind at ease. When it comes time for your device's clearance, it'll feel like a breeze with the support and guidance of your Gurus.
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Rest assured, we’ve got your back

After supporting our customers through 2,000+ ISO 13485 certifications, we've learned exactly what it takes to ensure medical device companies receive market-clearing certifications. We'll help you eliminate the guesswork by demystifying the process for you and your device.
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Pass with flying colors

We're proud to say we've supported and celebrated thousands of passed audits with our customers. By leveraging our team's hard-won industry expertise, we know how to apply best practices for audit preparation with all of our customers.
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We’re ready to share our knowledge with you

More than 1,000 medical device companies worldwide count on us. Whether you're launching your device or navigating regulatory climates, you can count on us. We're here to be a trusted advisor and to ensure your products thrive in the market.

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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$ 125 k

saved on average per project

3

months faster to market

402

hours saved on low value-added activities
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