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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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QMS Software for MedTech Companies

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
Is Your QMS Slowing You Down?
Chasing signatures, scrambling through audits, and manually building traceability isn't why you got into this business. With built-in efficiency designed for MedTech, you can focus on what's important: improving more lives, faster.
Your Old System
Greenlight Guru QMS
Old Way QMS
QMS New Way with Greenlight Guru

Trusted by 1,000+ medical device companies worldwide.

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“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 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 platform and achieve true
MedTech Lifecycle Excellence.

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.

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.

Product Development

 

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

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.

SOP Templates

 

Get over 48 audit-tested and customizable templates. Streamline system set-up, ensure compliance, and follow industry best practices from the start.

 

 

 

 

 

 

Book Your Free Demo Today

Leading medical device companies in more than 600 cities in 50 countries on 6 continents implement their quality culture using our software.

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