Quality Management System QMS for MedTech

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 QMS

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 Pharma Med Ltd.

“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 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.

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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

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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

https://blog.greenlight.guru/hubfs/Puzzle_Med-875x530-1.jpg

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

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.

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

Maxime Rochan Director of Quality, Puzzle Medical

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.

No results

Case Study

Puzzle Medical Beats Their Go-To-Market Timeline by 5 Months, Saving 360 Hours Per Employee/Year

"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 ...

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Case Study

Monitored Therapeutics Inc. Passes 6 Audits and Scales Office by 7x Over 1 Year

“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

Tenacore Migrates Entire QMS Off of Paper and Passes ISO 13485:2016 Within 10 Months

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

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What if Quality Management Was Your Easiest Task?

See what's possible.

75 %

Reduction in time needed to set up a QMS

50 %

Reduction in time preparing for audits

35 %

Reduction in time to market

Greenlight Guru QMS

Featured Capabilities:

SMART-TRIAL by
Greenlight Guru

Featured Capabilities:

Greenlight Guru Academy

QMS Software

Ensure Compliance.
Lower Risk.
Accelerate Your Timelines.

Trusted by leading medical device companies worldwide.

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.

One Interconnected Quality Ecosystem

Unify your whole team under one easy-to-use quality management system and achieve true
MedTech Lifecycle Excellence.

Our Customers Say It Best

No results

Puzzle Medical Beats Their Go-To-Market Timeline by 5 Months, Saving 360 Hours Per Employee/Year

Monitored Therapeutics Inc. Passes 6 Audits and Scales Office by 7x Over 1 Year

Tenacore Migrates Entire QMS Off of Paper and Passes ISO 13485:2016 Within 10 Months

What if Quality Management Was Your Easiest Task?

75 %

50 %

35 %

Greenlight Guru QMS

Featured Capabilities:

SMART-TRIAL by Greenlight Guru

Featured Capabilities:

Greenlight Guru Academy

QMS Software

Ensure Compliance.Lower Risk.Accelerate Your Timelines.

Trusted by leading medical device companies worldwide.

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.

One Interconnected Quality Ecosystem

Unify your whole team under one easy-to-use quality management system and achieve true MedTech Lifecycle Excellence.

Our Customers Say It Best

No results

Puzzle Medical Beats Their Go-To-Market Timeline by 5 Months, Saving 360 Hours Per Employee/Year

Monitored Therapeutics Inc. Passes 6 Audits and Scales Office by 7x Over 1 Year

Tenacore Migrates Entire QMS Off of Paper and Passes ISO 13485:2016 Within 10 Months

What if Quality Management Was Your Easiest Task?

75 %

50 %

35 %

SMART-TRIAL by
Greenlight Guru

Ensure Compliance.
Lower Risk.
Accelerate Your Timelines.

Unify your whole team under one easy-to-use quality management system and achieve true
MedTech Lifecycle Excellence.