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COMPLETE GURU SERVICES

Direction, innovation, and guidance at each stage in your journey.

Partner with our Gurus who will help you efficiently navigate medical device regulations, reduce risk, and prepare for a successful launch.

STRATEGIC GURU ADVISING

Gain clarity around regulatory requirements and leverage industry best practices to confidently meet your objectives at each stage of your medical device journey.

Benefits

  • Meet regularly in focused 1-hour sessions
  • Customized plan designed to meet your needs
  • Support mission-critical processes
  • Library of SOPs with regular updates

GURU ASSIST

Save time with an industry sounding board on best practices right when you need it, and expedited software support.

 

Benefits

  • On-demand assistance and coaching
  • Easy, in-app functionality
  • Expedited software support
  • Library of SOPs with regular updates

Strategic Guru Session Topics INCLUDE 
  • Quality system design recommendations
  • Quality documentation review
  • Design control best practices
  • DHF / Technical File evaluation
  • Risk management structures
  • Product submission review
  • Quality event support
  • CAPA & Complaint definition
  • Regulatory strategy and planning
  • Audit preparation and practice
 

 

We have worked with hundreds of customers and know many of the questions you will have.

Questions we assist with every day:

 

  • What standard operating procedure templates are most important for us?
  •  
  • How often should we run internal audits?'
  •  
  • Can you recommend a naming schema for the documents in my QMS?
  •  
  • How should I run an effective design review using Greenlight Guru?
  •  
  • Can you give me a few examples of design inputs?

COMPLETE GURU SERVICES

Direction, innovation, and guidance at each stage in your journey.

Partner with our Gurus who will help you efficiently navigate medical device regulations, reduce risk, and prepare for a successful launch.

I think you can rely on the Greenlight Guru team to have your best interests at heart, they talk about their mission being to help improve the quality of life by improving the quality of the medical device industry (not an exact quote) and they walk the walk. It's never too early or too late to start a conversation with them - so far I as can tell, the earlier the better.

Jacob Lawson, Product and Process Development Scientist, Canterbury Scientific Ltd
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SOP TEMPLATE LIBRARY

streamline the setup of your quality management system

We've created 70+ audit-tested procedures, work instructions, and forms to save you time during implementation and put your team at ease during audits.

Benefits

  • Save time in QMS implementation and establish a quality manual
  • Reduce compliance risk by ensuring proper documentation in the face of an audit
  • Avoid later rework in updating core documents for the quality system
  • Follow medical device industry best practices from the start

our audit-tested QMS templates INCLUDE 

Quality Manual

Management Review Template

Project and Risk Plans

Clinical Evaluation Templates

Quality Event Procedures and Templates

Supplier Survey Forms

 

SOP TEMPLATE LIBRARY

streamline the setup of your quality management system

We've created 70+ audit-tested procedures, work instructions, and forms to save you time during implementation and put your team at ease during audits.

"We passed our stage 1 notified body audit with 0 nonconformances! Very big thanks to gg for the help, including the templates provided – a great help. My quality manual is a copy & paste from yours.”


"With these templates, we were able to get our system up & running quicker than we expected. We were able to tackle the documentation in-house without wasting additional time or resources.”

MEDICAL DEVICE IS ALL WE DO.

Our expertise is a result of our life’s work. We offer in-house gurus with 10+ years of industry expertise as well as a worldwide partner network.

  • 75 YEARS
    Industry experience
  • 275,000
    Podcast listeners
  • #1
    Blog and podcast
    in the industry
  • 150,000+
    Rely on us for the
    latest in quality

Interested in our Guru Servces?
Reach out to learn more.

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