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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

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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.

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Quality Management Software (QMS Software)

Ensure Compliance.
Lower Risk.
Accelerate Your Timelines.

Unlock efficiency with the leading cloud-based QMS software designed to improve speed and quality while lowering risk and cost.

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On average, our customers experience:
75 %
Reduction in time needed to
set up a QMS
50 %
Reduction in time preparing
for audits
35 %
Reduction in time to market
40 %
Reduction in number of
audit findings
Calculate Your ROI
Is Your QMS Slowing You Down?
Chasing signatures, scrambling through audits, and manually building traceability isn't why you got into this business. With efficiency designed for MedTech, you can focus on what's important: improving more lives, faster.
Your Old System
Greenlight Guru Quality
Old Way QMS
NewWay_OldWay_1224

Trusted by leading medical device companies worldwide.

“Greenlight Guru was the only way we could get our small team to move really quickly with a QMS.”
Monti Lejia
CEO of Delta Development Team
“I'd call them the Tesla of the medical device eQMS software.”
Adnan Ashfaq
Founder of Simplimedica
“Greenlight Guru's software is expensive on day one, and dirt cheap on day two.”
Daniel Powell
CEO of Spark Biomedical
“What we pay to have Greenlight Guru is repaid in efficiency.”
Clive Seymour
CEO of Canterbury Scientific
MedTech Quality Solutions

Built To Support Medical Device Companies

Your QMS software is optimized for the unique challenges and strict requirements of MedTech. Connect your people, processes, and data under one single source of truth.

Pre-validated per FDA & ISO best practices

Ensure compliance from the start without lifting a finger. Your software comes aligned with 21 CFR Part 820, ISO 14971:2019, ISO 13485:2016, and FDA requirements.

End-to-end traceability

Enhance team collaboration, break down information silos, and maintain a single source of truth. By reducing risk of noncompliance, your device can stay on the market longer.

Scaleable across your product lifecycle

Create a culture of quality from idea, to development, to post-market surveillance under one connected system.

Real-time audit readiness

Spend less time digging through spreadsheets and binders with every auditor request. With one interconnected, living database, you can get through audits with fewer issues in just a few clicks.

Platform Tools

One Interconnected Quality Ecosystem

Unify your whole team under one easy-to-use quality management system.

Document Management

Your documents should increase efficiency, not slow you down. Seamlessly review, approve, update, and link documents all in the cloud. All with a click.

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Design Controls and DHF

The most advanced design controls functionality for MedTech. Intuitively integrate risk while you design, manage traceability, and maintain a living history file.

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Product Development

Connect your quality and product development teams to streamline collaboration, increase efficiency, and reduce risk across your product lifecycle

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Quality Process Management

Give your team the tools they need to enable a culture of quality: compliant, yet flexible workflows for CAPAs, customer feedback, and audits.

Training Management

Your company's success and your team's skills go hand in hand. Create, manage, and track individual or role-based training conveniently inside your QMS.

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SOP Templates

Get over 70 audit-tested and customizable templates. Streamline system set-up, ensure compliance, and follow industry best practices from the start.

Our Customers Say It Best

Establish Your QMS
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Greenlight Guru has been instrumental for us, as a small team, while we efficiently navigate the quality management system process and with developing our FDA submission.

Ryan Nolan Co-Founder / VP of Clinical Operations Photonicare
Create A Culture of Quality
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
Impress Auditors
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.
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 for us, as a small team, while we efficiently navigate the quality management system process and with developing 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.

What if Quality Management Was Your Easiest Task?

See what's possible with Greenlight Guru Quality.

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75 %

Reduction in time needed to set up a QMS

50 %

Reduction in time preparing for audits

35 %

Reduction in time to market

Frequently Asked Questions

What exactly is quality management software?

Quality management software refers to a software solution that houses a company’s quality management system (QMS). The QMS is a formalized system that documents the policies, procedures, documentation requirements, and processes that a company uses to ensure their products are safe and effective for the end-user. Quality management software provides businesses with a single source of truth for their QMS, as well as automating processes and simplifying documentation and record-keeping.

What types of quality processes can be managed with QMS software?

All of your company’s quality processes can (and should) be managed within your QMS. These include design controls and risk management, training management, supplier management, change management, document controls, CAPA, and internal auditing—to name a few.

How secure is that data in quality management software?

Given the importance of the documents and records that live within a QMS, quality management software will typically employ a number of security measures like two-factor authentication and permission-based access. QMS software suppliers often obtain international certifications via independent third parties as proof of their commitment to security. For instance, Greenlight Guru is Service Organization Controls (SOC) 2 certified, and also holds certifications for ISO 27001:2013 and ISO 9001 standards.

What is the process for QMS implementation?

The process for implementing a QMS will depend on the state of your current quality system. If you’re starting from scratch, Greenlight Guru’s onboarding and implementation team will help you build out a new QMS within the system with the help of 80+ audit-tested and customizable SOP templates. If you’re migrating an existing QMS, the O&I team will help you formulate a plan for migration and guide you in prioritizing the most important elements of your QMS.

Is Greenlight Guru’s software scalable?

Yes, Greenlight Guru’s QMS software is scalable. We work with startups, enterprise customers, and everyone in between. Our solution is built to meet you where you are right now and grow with you as your business expands and your needs increase.
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