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Built-in controls that align with 21 CFR Part 820 and ISO 13485:2016
 
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Flexible review and approval workflows with Part 11 compliant audit trail and e-Signatures
 
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Fully integrated Design Controls and Risk Management aligned to ISO 14971 requirements
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Link anything drives full traceability
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drive collaboration with task management, comments, and NOTIFICATIONS
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ZERO EFFORT SYSTEM VALIDATION, AT NO ADDITIONAL CHARGE

Yes, I'd like to see how Greenlight Guru Compares

Workflows aligned to FDA & ISO standards for medical device processes

  • 21 CFR Part 11 Compliant
  • FDA 21 CFR Part 820
  • ISO 13485:2016
  • ISO 14971:2019
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G2 helps businesses discover, buy, and manage software by providing real reviews, from real users, in real-time.

The Grid Report for Quality Management Systems highlights the leading QMS solution providers ranked by customer satisfaction (based on user reviews) and market presence (based on market share, vendor size, and social impact).

Greenlight Guru’s Medical Device Quality Management Software has been named a Leader in the Quality Management Grid Report 8+ consecutive quarters based on receiving a high customer satisfaction score and having a large market presence.

- BASED ON REAL USER REVIEWS - 

95% of users believe the solution and company are headed in the right direction

93% of users reviews rated it 4 or 5 starsg2 crowd-png-2

92% of users said they would be likely to recommend Greenlight Guru

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4.5/5 stars on Capterra
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4.5/5 stars on Featured Customers 
Greenlight Guru VS General-purpose  eQMS Solutions

Core Capabilities

 

General-purpose eQMS solutions lack the purpose-built capabilities that medical device companies need to integrate their core QMS processes to build safe, effective products.

Ryan-Shelton
“We've been using Greenlight Guru for the better part of three years now and it really simplifies quality management. It's very easy to get all of our team on the same page and effortlessly trace various efforts through the system. The Greenlight Guru team is one of the best I've ever worked with. ”
Ryan Shelton, CEO
GREENLIGHT GURU VS GENERAL-PURPOSE EQMS SOLUTIONS

Industry alignment

 

General-purpose eQMS solutions lack the purpose-built capabilities that medical device companies need to maintain compliance with industry regulation and achieve closed-loop traceability. 

Evan Luxon

"I have a high degree of confidence that as changes to regulations occur, I won't have to worry about being out of compliance because we are using Greenlight Guru."

Evan Luxon, Co-Founder and CEO

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GREENLIGHT GURU VS GENERAL-PURPOSE EQMS SOLUTIONS

EASE OF USE & SYSTEM SCALABILITY

 

 

General purpose eQMS solutions may cover the basics of a QMS, but configuring, implementing, and managing them will cost you more time and money in the long run.

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"I believe the quality system I've instituted actually gives me a competitive advantage against a lot of the large companies I used to work for."

Dan Holton, Founder and CEO

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