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BE AUDIT READY 

AT A MOMENTS

NOTICE

A connected quality ecosystem where every record of your QMS is organized, centralized, and traceable

 

See it in action →

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1
It's the leading QMS designed specifically for the medical device industry, enabling a new way to manage your quality program.
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Track and manage quality events and associated follow up tasks digitally.
3
Capture usable quality metrics in real-time.
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Assure your team's documentation is audit ready in real time.
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Drive traceability throughout your quality, design, and risk processes.
   

 

 

  • 21 CFR Part 11 Compliant
  • Workflows aligned to FDA and ISO standards for medical device predefined processes
  • FDA 21 CFR Part 820
  • ISO 13485:2016
  • ISO 14971:2019
QE Automation
NEW

Automate your quality event workflows

Avoid the rework and excess documentation involved with each new quality event opened, by implementing custom CAPA, Nonconformance, Customer Feedback, or Audit workflows to automate the step-by-step process.

Increase your team’s efficiency when managing post-market quality events with custom-built, automated workflows while still working within the guardrails of Greenlight Guru.

The connected quality platform built

for medical device companies

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POST MARKET SURVEILLANCE
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Simplify Quality Processes 

Enable a culture of quality by managing quality events like CAPA, Customer Feedback, and Audits in Workspaces with 21 CFR Part 11 compliant review and approval workflows to collaborate with internal and external stakeholders

See how teams are streamlining quality processes → 

 

SUCCESS STORY: How SimplicityMD used Greenlight Guru to explain complex  processes  Read the Success Story

RISK MANAGEMENT
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MANAGE RISK WITH EASE

Easily incorporate ISO 14971:2019 compliant risk-based controls into your quality and design processes throughout both development and post-market surveillance stages.

See integrated Risk Management in action → 

TRACEABILITY
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DRIVE END TO END TRACEABILITY - FROM DESIGN CONTROLS TO POST MARKET SURVEILLANCE

Assure traceability throughout the product lifecycle by easily linking post market activities to Design Controls, Risks, and Documents 

See it in action → 

 

RELATED WEBINAR: FDA partners with Greenlight Guru: Case for Quality webinar  series  Listen to the Webinar

DOCUMENT MANAGEMENT
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EASILY ACCESS UP-TO-DATE DOCUMENTS

Speed up reviews and approvals by keeping your documents, records, and procedures organized, up-to-date and always accessible to the right people with robust sharing and role based security.

See Advanced Document Management in action → 

 

SIMPLIFY QUALITY IN A RAPIDLY CHANGING REGULATORY ENVIRONMENT WITH GREENLIGHT GURU

G2 - Spring 2020 (1)-1Leader - Fall21

G2 Crowd provides real-time and unbiased user reviews to help you objectively assess what software is best for your business.

Read All Reviews

August 7, 2017
“Fantastic Product and Even Better Team”
The GG team goes out of their way to help us meet our business objectives. They are knowledgeable in the regulatory and quality management space and are always trying to improve their software and user experience.
Ryan Shelton
Validated Reviewer
Verified Current User
May 22, 2018
“One Stop Shop for MD QMS”
I love that everything is 'under one roof', the design, document control, training, change management, NC,s CAPAs, Feedback and Audits. I really love the risk within design, it is set out clearly, easy to use and clear to see the risks at a glance. I also love that Greenlight have a continual improvement approach and new features being added to enhance the usability and performance from time to time. Also, their customer service is top class. I really don't know how I would do my job without it!
Maria McGrady
Validated Reviewer
March 25, 2021
“Simplified Traceability and Risk”
I love how simple the program is and how it takes a lot of time-consuming unnecessary information found in historical QMS systems and replaces it with the critical focused details to move things along quickly.
User in Medical Devices (Mid-Market)
Validated Reviewer
Verified Current User
March 22, 2021
“Great software for QMS activities and document management”
As a small business implementing a QMS for medical device design/manufacturing, it has proven to be an incredibly valuable tool.
Jason C.
Validated Reviewer
Verified Current User
April 1, 2021
“A very good start with GG!”

With Greenlight Guru, I can follow all the steps of our quality management system and make sure all regulatory requirements are met. The most significant benefit for me is being able to accurately verify that all risks are managed and that all design checks are carried out. The software allows us an extremely rigorous follow-up which is and will be a big help for us.

Camille
Validated Reviewer
April 1, 2021
“Greenlight Guru has made Design Controls and Project Planning easier to execute and manage”

We are solving document control and design controls with the Greenlight Guru Software. It is easier to release documents and gather signatures for controlled documents. The design controls system has made project management more manageable by having all the documents in one place.

Mike S.
Validated Reviewer
Verified Current User
March 26, 2021
“Demystifying QMS and Regulatory Requirements”

The Greenlight Guru customer success team has helped us navigate the entire process so far, with no ask too large and no question left unanswered. It has by far been one of the best customer service experiences I've had to date.

Kyle P.
Validated Reviewer
Verified Current User
March 16, 2021
“You do not have to do it alone!”

Having come from one of the largest medical device companies globally to a start-up with no QMS, yet alone, an eQMS, the transition to Greenlight has saved my team countless hours and provided an ability, especially during COVID, to do remote approvals of documents, assign tasks, and give visibility to the appropriate team members of a variety of modules in order to collaborate and move forward with pre- and post-market activities.

Adam C.
Validated Reviewer
Verified Current User
March 26, 2021
“Modern QMS Software and Outstanding Customer Service”

#1 - Customer Service! Our Customer Success Manager and Medical Device Guru are both incredibly patient and responsive anytime that my team and I email them questions. They are also genuinely appreciate unfiltered feedback from their customers. Their positive attitudes and attentiveness, specifically throughout our onboarding process, has been instrumental to our success in implementing GG. We did NOT feel like we were left on our own during this process.

Amanda P.
Validated Reviewer
Verified Current User
March 13, 2021
“Greenlight Guru allowed us to get our QMS up and running in less time than we ever thought possible”

The biggest gain for us has been being able to get our QMS up and running from scratch in less than 3 months. It is reassuring knowing that the system helps us to be ISO 13485 and 14971 compliant. We have found GG to be very useful in documenting our design controls and risk matrix. We really like how the system allows you to connect these areas.

Azeret Z.
Validated Reviewer
Verified Current User

See how our software enables a culture of true quality and accelerates outcomes 

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