implement-advance-quality-culture-guru-logo

ELECTRONIC QMS TEMPLATES & CUSTOMIZATION

SERVICES THAT HELP YOU BRING QUALITY DEVICES TO MARKET FASTER.

We’ll set up your quality management system and help implement your procedures, forms and templates.

TEMPLATE PACKAGES

Best for teams implementing a QMS for the first time or revamping their current QMS. Our audit-tested procedures, forms and templates will save a ton of time during audits and inspections.

Benefits

  • Full QMS procedures, forms and templates that are proven, audit tested.

CUSTOMIZATION & TRAINING PACKAGES

Best for teams inexperienced in regulatory processes or those who prefer outsourcing staff training to us. Our training will make sure that your team is armed with best practices in quality management (Requires the purchase of a template package).

Benefits

  • Guidance on QMS template configuration
  • QMS customization and implementation
  • Remote-based training on:
    • ISO 13485 QMS
    • FDA 21 CFR 820
    • ISO 14971 Risk Management
    • Applied Design Controls
    • Applied Risk Management

ELECTRONIC QMS TEMPLATES & CUSTOMIZATION

SERVICES THAT HELP YOU BRING QUALITY DEVICES TO MARKET FASTER.

We’ll set up your quality management system and help implement your procedures, forms and templates.

The Greenlight Guru team goes out of their way to help us meet our business objectives. They are knowledgeable in the regulatory and quality management space and work with us to ensure we are building our QMS the right way.”
Ryan Shelton, CEO, PhotoniCare
implement-advance-quality-culture-guru-logo

CUSTOMER SUCCESS SERVICES

ENSURE QUALITY THROUGHOUT YOUR ENTIRE DEVICE LIFECYCLE.

We’ll provide clarity around the regulatory process and give you the tools you need to manage risk and maintain visibility.

BASIC PACKAGE

Monthly consulting sessions to support mission-critical processes, time-saving documents and more

Dedicated customer success expert

Design Controls and Risk Management support

Software Validation Support

21 CFR Part 11 IQ/OQ/PQ Qualification Document Packs

PREMIUM PACKAGE

Weekly consulting sessions to support mission-critical processes, time-saving documents and more

Dedicated customer success expert

Design Controls and Risk Management support

Software Validation Support

21 CFR Part 11 IQ/OQ/PQ Qualification Document Packs

Dedicated phone support

QMS process checkups to help ensure your processes are compliant and quality-driven

CUSTOMER SUCCESS CONSULTING INCLUDES SUPPORT ON

Quality Assurance

  • Quality System Design and Implementation
  • Team Training Support
  • Quality Strategy
  • CAPA Support
  • Interim Management
  • Gap Analysis
  • Mock FDA Inspection

 

Regulatory Compliance

  • Regulatory Strategy
  • Design Control / DHF / Technical File
  • Regulatory Submissions
  • Gap Analysis
  • Project Management and Product Development
  • FDA Warning Letter and 483
  • Observations
  • Interim Management
  • Risk Management
  • ISO Audit Observation / Noncomformance

 

Training

  • ISO 13485:2016
  • Design Controls, FDA 21 Part 820.30
  • FDA QSR 21 CFR 820
  • CAPA & Complaints
  • ISO 14971 Risk Management
  • Part 11

CUSTOMER SUCCESS SERVICES

ENSURE QUALITY THROUGHOUT YOUR ENTIRE DEVICE LIFECYCLE.

We’ll provide clarity around the regulatory process and give you the tools you need to manage risk and maintain visibility.

I can't tell you how much of a burden as been lifted off of me since working with Greenlight Guru. They're a life saver.
Matt Bellman PhD, Co-founder & CTO, Myolyn

QUALITY 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
  • 50,000
    Podcast listeners
  • #1
    Blog and podcast
    in the industry
  • 28,000
    Rely on us for the
    latest in quality

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

Talk to a Guru