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Essentials

STARTUP KIT

Essentials include: 

  • Design Controls (1 Project)
  • Risk Management
  • Advanced Document Management
  • Change Management
  • Supplier Management
  • Task Management

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EASILY ACCESS AND CONTROL DOCUMENTS.

  • Part 11 Compliant E-signatures
  • Flexible Review & Approval Workflows
  • Document Revision Control
  • Proper Access & Usage

DOCUMENT YOUR DESIGN CONTROLS WITH FULL TRACEABILITY.

  • Multi-level Design Controls
  • Intuitive & Automatic Traceability Matrix
  • Digital Design Reviews
  • Living DHF

GAIN NEW VISIBILITY AND MITIGATE RISK.

  • Aligns with ISO 14971:2019
  • Integrated & Accessible Platform-wide
  • Custom Risk Acceptability Matrix
  • Living Risk Management File

Plus

ALL-IN-ONE SOLUTION

Essentials package and: 

  • Design Controls (Unlimited Projects)
  • Training Management
  • CAPA Management
  • Audit Management
  • Nonconformance Management
  • Complaint Management
  • Analytics

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CREATE A CONNECTED QUALITY ECOSYSTEM.

  • Purpose-built controls for medical device companies
  • Comprehensive, end-to-end, wholly traceable system
  • Effectively manage and connect design controls, risk, and quality events

STREAMLINE TEAM ACTIVITIES.

  • Efficiently organize, assign, and track training activities
  • Enhanced collaboration & productivity
  • Increase visibility & control into processes and procedures

ACHIEVE COMPLIANCE AND STAY AUDIT READY.

  • FDA, ISO, MDSAP, & EU MDR Best Practices
  • Complete Part 11 compliant audit trails
  • Quickly & easily provide objective evidence
  • More accurate & up-to-date traceability throughout the system

Professional

INTELLIGENT SOLUTION

Plus package and: 

  • Visualize
  • Intelligent Document Management powered by HaloSM

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VISUALIZE YOUR QMS

  • See and interact with items in a centralized view
  • Understand relationships between items in your QMS
  • Virtual linking between items (powered by machine learning and natural language processing)

ANALYZE & PREDICT IMPACT

  • Change and update recommendations powered by AI and machine learning
  • Streamline the change control process
  • Reduce risk in missing key elements of a change

DATA-DRIVEN

  • Eliminate human error in identifying relationships and building traceability
  • Increased visibility into quality performance
  • Efficiently collect and evaluate trending quality information

Guru Services

ENHANCE YOUR TEAM WITH AN EXTENSION OF OURS.

Our seasoned medical device Guru's will ensure that you have what you need for your QMS implementation to run smoothly, while also providing clarity around the regulatory process and best practices for managing quality throughout your device's lifecycle.

DEDICATED QUALITY & REGULATORY EXPERT

  • Training 
  • Quality Assurance
  • Regulatory Compliance 
  • Audit Support

QMS Templates

GET STARTED WITH THE RIGHT DOCUMENTATION.

These audit-tested procedures, work instructions, and form will streamline the implementation of your quality management system and save you time during implementation and audits.

 

AUDIT-TESTED TEMPLATES FOR YOUR QMS

  • Quality Manual
  • Management Review Template
  • Project and Risk Plans
  • Supplier Survey Forms
  • Quality Event Procedures and Templates

Still not sure which plan is right for your team? 

Give us a call. 

+1 (317) 960-4220
Customer Success

Greenlight Guru is more than just software. 

Our Customer Success team is here to do more than solve technical issues. At Greenlight Guru, we value fanatical support. That means our noteworthy Customer Success and Medical Device Guru teams on your side to ensure that you and your team are always supported and on track to achieve success. They are here to help your team implement, maintain, and extract full value from your QMS to further your business. Your outcomes shape our outcomes - when you succeed, so do we.

 

Phone, Video Meeting, and Email Support

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Help Documentation & Live Training

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Industry Knowledge & Support Access

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G2-Crowd

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

Frequently Asked Questions

Do I need to buy onboarding services?
Are there any overage fees? Or data limitations?
Will I have to pay for software upgrades?
How is the software deployed?
What type of support is available to users?
Still not sure how Greenlight Guru’s medical device QMS software can help your business? Talk with us.
+1 (317) 960-4220