<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">

THE MEDICAL DEVICE

QUALITY SYSTEM

YOU CAN TRUST

 

Empower your team with a software platform that accelerates device clearance timelines

See it in action →

exec-1
1
Accelerate product development efforts and improve the quality of regulatory submissions
2
Leverage quality as a strategic advantage to protect your brand and impact the top and bottom lines
3
Grow faster with a quality system that allows you to scale and navigate different international markets
4
Achieve peace of mind knowing your quality system can stay ahead of compliance changes
5
Proactively identify and reduce risk

 

 

  • 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

Medical Device Quality management software that enables a culture of true quality and accelerates outcomes

traceability-edit-01 audit-readiness Premarket-Quality-Management-Software-go-risk-management-screenshot usability
Audit Readiness
traceability-edit-01

BE SUBMISSION & AUDIT READY WITH END TO END TRACEABILITY

With a fully connected QMS that incorporates design controls and risk, your team can assure traceability throughout the product lifecycle in order to expedite device clearance timelines and navigate audits with ease.

See it in action → 

 

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

COLLABORATION
audit-readiness

UNITE YOUR TEAM

Drive collaboration in a centralized workspace for managing device requirements, risk, documents, & quality activities while leveraging Part 11 compliant review and approval workflows to collaborate with internal and external stakeholders. 

See how teams are collaborating with Greenlight Guru to accelerate outcomes →  

 

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

Risk Management
Premarket-Quality-Management-Software-go-risk-management-screenshot

REDUCE YOUR RISK OF NON-COMPLIANCE

Mitigate the likelihood of missed product development milestones or regulatory delays in achieving device clearance. By taking a proactive approach to managing risk activities over the course of the product lifecycle, your team will be positioned to drive higher quality outcomes for patients and partners. 

See how teams are controlling patient and business risk → 

 

RELATED EBOOK: The Definitive Guide to ISO 14971 Risk Management for Medical  Devices  Read the eBook

Usability
usability

DON'T LET QUALITY BE A BOTTLENECK

With a turn-key medical device quality software platform that offers audit-proven quality templates, built-in controls, medical device expert services, and a modern interface that is easy for teams to learn and use, your team can focus on value added activities that lead to efficient growth.

Learn how innovative teams are scaling quality → 

 

The low risk quality system powering high growth medical device companies around the globe

G2 - Spring 2020 (1)-1.       G2 crowd [general] badge-1 G2-badge

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
November 21, 2021
“Finally...eQMS software I have confidence in”

An efficient and controlled way of managing our documentation is now much more straightforward. I am confident that we are compliant with using GG

Kelly W.
Validated Reviewer
Verified Current User
November 19, 2021
“An Intuitive, Supportive, and Forward-thinking E-QMS”

Greenlight Guru are ahead of the game in terms of incorporating workflows which lead to compliance to ISO 13485:2016 and 21 CFR Part 820 regulations. The Change Management and Document Control functionalities make it easy to control records and document approvals especially in a world that is moving away from the traditional 'in-office' setting to remote working

Jacob S.
Validated Reviewer
Verified Current User
November 18, 2021
“User friendly eQMS that comes with a great team”

The software is user-friendly and customizable enough to meet your needs if you already have an existing QMS set up. But honestly, the best part is the team we work with for our transition process. They make the difference in this being a good experience. Their friendliness and wealth of knowledge about the medical device industry made the process so easy

Cynthia
Validated Reviewer
Verified Current User
November 17, 2021
“From Paper to electronic in less than 6 months”

With Greenlight Guru, we have been able to solve training gaps, on-time completion of customer complaints and non-conformances, and change orders. Previously to Greenlight, we had complaints that sat uncompleted for over a year; now with GG we are able to close them in less than 30 days.

Stacy M.
Validated Reviewer
Verified Current User
November 10, 2021
“Documentation and Collaboration Made Easy”

Greenlight Guru is life-changing! The platforms for documentation and collaboration have made me and my team so much more efficient. It has turned the huge headache of regulatory compliance into a much more manageable task.

Courtney L.
Validated Reviewer
Verified Current User

Ready to learn more about how your team can accelerate outcomes and leverage quality as a strategic advantage?

See the Demo