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

How We Do It

We partner with MedTech companies in more than 600 cities across 50 countries and 6 continents. They implement their quality culture using our platform, and we equip them with the resources they need to succeed.

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1000 +

MedTech companies trust our platform

1700 +

510(k) clearances and CE markings

$ 125 k

saved on average per project

2000 +

ISO 13485 certifications

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Case Study

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

“Greenlight Guru’s Design Controls module is powerful and the traceability present across the entire QMS is my favorite part about the software. It makes remote collaboration so ...

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Case Study

Oticon Medical Continues Striving for Clinical Excellence

How SMART-TRIAL by Greenlight Guru is helping Oticon Medical, industry-leading medical device manufacturer of hearing aids, and why they have remained loyal customers for years.

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Case Study

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

“The biggest reason we chose Greenlight Guru was that their eQMS is designed for device manufacturers and developers. It is very specific to our needs”

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Case Study

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

"It’s scalable, it’s repeatable, and it’s audit-ready."

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Case Study

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

“Purchasing Greenlight Guru was the best decision for our needs. Their easy-to-use eQMS, SOP Templates, and expert Guru guidance were key to us being able to successfully navigate ...

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Case Study

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

"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 ...

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Case Study

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

“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 ...

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Case Study

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

“Having partners with common values is just as important as the product or services themselves.”

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Case Study

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

"If I were to quantify it, it's days of time saved. The cost of Greenlight Guru is repaid in efficiency."

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Case Study

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

"Greenlight Guru was the only way we could get our small team to move really quickly with a QMS."

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Case Study

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

"Showing traceability and documenting takes seconds in Greenlight Guru, compared to hours in a paper-based system."

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Case Study

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

"We wanted a QMS solution that was robust enough to grow with us, but simple enough to get us started."

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Case Study

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

“Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA submission.”

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Case Study

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

"I have a high degree of confidence that as changes to the regulations occur, I won't have to worry about being out of compliance because we are using Greenlight ...

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Case Study

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

"With Greenlight Guru, you've got software, but also what amounts to a personal consultant. Those connections are powerful."

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Case Study

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

"I highly recommend Greenlight Guru. They have taken a complex industry and made it into a product that’s simple to use.”

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Case Study

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

“Not having your Design control or Risk Management can be a $20M hair cut on the valuation of your company. I’ve seen first hand a small company being courted by a bigger ...

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Case Study

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

"As a design firm, our ISO 13485 certification is a competitive advantage. Greenlight Guru made getting it easy."

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Case Study

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

"I was actually a little nervous going into the audit, because it seemed too effortless."

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Case Study

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

"Greenlight Guru has already paid for itself in the added value brought to us by successfully flying through our quality audit."

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Case Study

Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru

The results? "A tenfold increase in efficiency with Greenlight Guru."

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Case Study

The Greenlight Guru Advantage - More Than QMS Software

"I believe the quality system I've institued actually gives me a competitive advantage against a lot of the large companies I used to work for."

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Case Study

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

"Less than 15 minutes later, the auditor had observed enough evidence to grant the scope expansion."

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Case Study

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

"The proof is in the pudding. We passed our California audit with flying colors. She was in and out in 2 hours and sent us our certificate in the mail, no questions ...

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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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