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SIMPLIFY MEDICAL DEVICE PRODUCT DEVELOPMENT

Do more value-added engineering work and less

compliance paperwork.

 

See it in action →

 

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1
Streamline the management of device requirements, risk, design reviews, and documentation. 
2
Device submissions are expedited and audit readiness is inherent to the software.
3
Easily demonstrate traceability between Design Controls and Risk with fully integrated risk management.
4
Drive accountability and collaboration across distributed teams to assure key development milestones are met.
5
Enable a renewed focus on developing better medical devices by focusing on value added tasks.
   
  • 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

Built for medical device product development professionals

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DESIGN CONTROLS
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AUTOMATICALLY MAINTAIN FULL TRACEABILITY

Easily manage multi-level device requirements in your traceability matrix and generate a completed Design History File on demand. Create detailed design control objects, link complex configurations, and attach documents with one click. 

See Design Controls in action → 

 

RELATED EBOOK: Ultimate Guide to Design Controls for Medical Device Companies  Read the eBook

 

RISK MANAGEMENT
risk-management

GAIN NEW VISIBILITY AND MITIGATE RISK

Incorporate risk controls into the product development process with the only cloud-based risk management solution that aligns with ISO 14971:2019. Demonstrate a risk-based approach to design with full traceability to related Design Controls and Components.

See how teams are taking an integrated approach to product risk→ 

 

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

PROJECT MANAGEMENT
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ACCELERATE DEVICE DEVELOPMENT TIMELINES

Meet aggressive deadlines by providing a centralized workspace where one or many teams can see each other's updates in real-time.

With FDA and ISO controls built-in, your team can stop wasting time chasing signatures, documenting offline design reviews, searching through email threads, and dealing with messy design transfers.

See how companies are launching medical devices faster with Greenlight Guru→ 

 

SUCCESS STORY: How Myolyn gained 510(k) clearance 48% faster than average with  Greenlight Guru  Read the Success Story

COLLABORATION
unified-visibility

ACHIEVE UNIFIED VISIBILITY

Drive accountability by managing device requirements and development efforts in a centralized workspace enabled with added-text formatting to enhance the technical details. Leverage tasks and flexible review and approval workflows to collaborate with internal and external stakeholders. 

See how teams are collaborating with Greenlight Guru→ 

 

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

LEARN MORE ABOUT GREENLIGHT GURU'S

DESIGN CONTROL AND RISK MANAGEMENT SOFTWARE

 

GLOBALLY TRUSTED, NO MATTER THE DEVICE

COMPLEXITY OR COMPONENT TYPES.

 Hardware   Software   SaMD

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G2 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 get started doing more value added engineering work and less compliance paperwork?

See the Demo