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[New Certifications]: Level Up Your MedTech Skills With New Greenlight Guru
Academy Courses
Get Started for Free


Guru Difference

 * Guru Edge
 * Customers Like You
 * Why Switch
 * Become a Partner
 * Meet Halo: AI / ML for MedTech
 * Our Mission

Product


MEDTECH LIFECYCLE EXCELLENCE PLATFORM

The solution that powers end-to-end product lifecycle excellence from idea to
commercialization to postmarket surveillance.

Learn More
See the Demo
 * Quality Management (QMS)
 * Experience Traceability - Modern QMS
 * Design Control
 * Document Management
 * Change Management
 * Training Management
 * CAPA Management
 * Nonconformance
 * Audit Management
 * Complaint Management
 * Supplier Management
 * Quality Recommendations (AI / ML)

 * Product Development
 * Product Management (Items, BOMs)
 * Product Change Management
 * Risk Management
 * Project Management
 * Engineering Change Management
 * Clinical Electronic Data Capture (EDC)
 * Strategy
 * Regulatory Intelligence
 * Validation

Solutions

 * By Function
 * Executives
 * QA / RA
 * Product / R&D

 * By Initiative
 * Migrating From Paper
 * Preparing for Regulatory Submissions
 * Managing Product Development
 * Becoming Audit Ready
 * Managing Postmarket Quality

 * By Device Type
 * Class I–III
 * IVD
 * SaMD
 * Combo Product

 * By Stage
 * Startup
 * Small Business
 * Enterprise

Learn

 * Resources
 * Academy
 * Blog
 * Case Studies
 * Checklists & Templates
 * eBooks & Guides
 * Glossary
 * Podcasts
 * Content Hub

 * Connections
 * Community
 * Industry Job Board
 * Partner Ecosystem

 * Events
 * Webinars
 * Live & Virtual Events

JOIN THE MEDTECH EXCELLENCE COMMUNITY

Learn More
Customer Experience

 * Our Customers
 * Customer Success
 * Validation

See the Demo
 * Guru Difference
   * Guru Edge
   * Customers Like You
   * Why Switch
   * Become a Partner
   * Meet Halo: AI / ML for MedTech
   * Our Mission
 * Product
   * Platform Overview
     * MedTech Lifecycle Excellence Platform (MLE)
   * Quality Management (QMS)
     * QMS Overview
     * Experience Traceability
     * Design Control
     * Document Management
     * Change Management
     * Training Management
     * CAPA Management
     * Nonconformance
     * Audit Management
     * Complaint Management
     * Supplier Management
     * Quality Recommendations (AI / ML)
   * Product Development
     * Product Development Overview
     * Product Management
     * Product Change Management
     * Risk Management
     * Project Management
     * Engineering Change Management
   * Clinical Electronic Data Capture (EDC)
   * Strategy
   * Regulatory Intelligence
   * Validation
 * Solutions
   * By Function
     * Executives
     * QA / RA
     * R&D
   * By Initiative
     * Migrating From Paper
     * Preparing for Regulatory Submissions
     * Managing Product Development
     * Becoming Audit Ready
     * Managing Postmarket Quality
   * By Device Type
     * Class I—III
     * IVD
     * SaMD
     * Combo Product
   * By Stage
     * Startup
     * Small Business
     * Enterprise
 * Learn
   * Resources
     * Academy
     * Blog
     * Webinars
     * Case Studies
     * Checklists & Templates
     * eBooks & Guides
     * Glossary
     * Podcasts
     * Content Hub
   * Connections
     * Community
     * Industry Job Board
     * Partner Ecosystem
   * Events
     * Webinars
     * Live & Virtual Events
 * Customer Experience
   * Our Customers
   * Customer Success
   * Validation

See the Demo


QMS SOFTWARE


AN EASY-TO-USE QMS

Who knew that'd be revolutionary?

See the Demo


800+ LEADING MEDICAL DEVICE COMPANIES IMPLEMENT THEIR QUALITY CULTURE USING OUR
QMS SOFTWARE




THE CAPABILITIES YOU WANT WITH THE INSIGHTS
YOU NEED

The only Quality Management Software designed to help MedTech teams deliver
innovations to market, streamline compliance, and focus on quality — all in one
end-to-end platform.


YES, IT’S POSSIBLE TO LOVE YOUR QMS


FOR MEDTECH TEAMS, FRICTION AROUND QUALITY AND COMPLIANCE IS THE ULTIMATE FOE.
STITCHING TOGETHER SINGLE-POINT SOLUTIONS AND ADDRESSING THEIR GAPS SLOWS YOU
DOWN AND STALLS YOUR GROWTH. GREENLIGHT GURU ELIMINATES FRICTION BY BRINGING
TOGETHER THE RIGHT INSIGHTS AND CAPABILITIES TO KEEP YOUR DATA CONNECTED IN AN
END-TO-END, VISUAL QMS PLATFORM THAT CONNECTS YOUR TEAM. NOW YOU ARE FREED UP TO
FOCUS ON WHAT REALLY MATTERS—IMPROVING QUALITY OF LIFE.

Achieve End-to-End Traceability

Easily trace CAPAs all the way back to your design controls so you can focus on
accelerating your business.

Automate Quality Processes

Drive your processes step-by-step with custom workflow templates built into your
QMS.

Follow FDA/ISO Best Practices

The only QMS software with the latest FDA and ISO best practices specific to
MedTech companies built into every feature.

Visualize Connections Within Your QMS

Better comprehend and communicate relationships while keeping track of the
details and trending quality information.


THE ONLY QMS PLATFORM BUILT FOR MEDTECH TEAMS

Greenlight Guru is the only modern, purpose-built solution to give MedTech
companies an end-to-end system to manage the lifecycle of their product — all in
one place.

Easily Access Up-to-Date Documents



Work on the most current version and save time with Part 11 compliant
e-signatures, flexible review & approval workflows, and revision control.

Manage Change

Work on the most current version and save time with Part 11 compliant
e-signatures, flexible review & approval workflows, and revision control.

Manage Change

Maintain Device Traceability



Create detailed design control objects, link complex configurations, and attach
documents with one click.

Modern Design Controls

Create detailed design control objects, link complex configurations, and attach
documents with one click.

Modern Design Controls

Streamline Product Development



Integrate quality and risk management into your design and development processes
from the start.

Get Ahead of Risk

Integrate quality and risk management into your design and development processes
from the start.

Get Ahead of Risk

Manage Quality Processes Systematically



Remain compliant and manage Nonconformances, Audits, and CAPAs  throughout your
product lifecycle.

Always Audit Ready

Remain compliant and manage Nonconformances, Audits, and CAPAs  throughout your
product lifecycle.

Always Audit Ready

Enhance Team Collaboration



Communicate where your team works. Avoid unnecessary meetings and emails by
collaborating across apps.

Ensure Training Compliance

Communicate where your team works. Avoid unnecessary meetings and emails by
collaborating across apps.

Ensure Training Compliance


Your End-to-End Platform


ENABLE A CULTURE OF TRUE QUALITY

A Connected Quality Platform Built for MedTech Companies


FOR PRODUCT TEAMS

Do more value-added engineering work and less compliance paperwork.

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

Your End-to-End Platform


ENABLE A CULTURE OF TRUE QUALITY

A Connected Quality Platform Built for MedTech Companies


FOR QUALITY TEAMS

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

 * Simplify quality in a rapidly changing regulatory environment
 * Track and manage quality events and associated follow-up tasks digitally
 * Capture usable quality metrics in real-time
 * Assure your team's documentation is audit-ready in real-time
 * Drive traceability throughout your quality, design, and risk processes
   
   




FOR LEADERS

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

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




ARE YOU READY TO EXPERIENCE THE GREENLIGHT GURU DIFFERENCE?

With solutions to improve every stage of your product lifecycle and a team
dedicated to supporting you, achieving excellence has never been easier.

See the Demo

$ 125 K

saved on average per project

3

months faster to market

402

hours saved on low value-added activities

 * About
   * Our Mission
   * Careers
   * Partner Ecosystem
   * Trust & Security
   * Support
   * All the Latest News
   * Contact Us
 * Product
   * MLE Platform
   * Quality Management (QMS)
   * Product Development
   * Regulatory Intelligence
   * Clinical EDC Software
   * Strategy
   * Validation
   * Pricing
 * Use Cases
   * Design Control & DHF
   * Document Management
   * Risk Management
   * Change Management
   * Training Management
   * CAPA Management
   * Complaint Management
   * Nonconformance
   * Project Management
   * Audit Management
   * Supplier Management
 * Resources
   * Medical Device Glossary
   * Free Industry Courses
   * Medical Device Job Board
   * Community
   * Podcasts
   * Webinars
   * Events
   * Blog
   * Customer Stories
   * Checklists & Templates
   * eBooks & Guides
   * Thought Leadership Articles
   * G2 Crowd Report
   * FAQ
   * Sitemap
   * Resource Hub
 * By Initiative
   * Migrating from Paper
   * Managing Product Development
   * Becoming Audit Ready
   * Preparing for Regulatory Submissions
   * Managing Postmarket Quality
 * By Team
   * Executive
   * QA / RA
   * Product / R&D



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