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Discover the new trends, outlooks, challenges, and opportunities in the MedTech industry in 2023.

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GREENLIGHT GURU ACADEMY

Level Up Your Medical Device Skills and Grow Your Career

From quick, practical lessons to comprehensive certifications, you’ll learn everything you need to know about keeping up with the medical device industry.

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Learn From the Best and Rise to the Top

  • On-demand courses that allow you to move at your own pace
  • Best practices and actionable training from industry experts
  • Gain exclusive benefits when you become a subscriber of Greenlight Guru Academy Advance

    Learn more about Advance →

Explore Our Courses

Created by industry professionals, Greenlight Guru Academy courses provide tangible takeaways for any individual looking to level up their medical device knowledge.

Behind the Stats: Expectations vs. Reality of Bringing a Device to Market

A talk by Etienne Nichols and Radhika Pandya of Greenlight Guru

MDR by the Numbers: Leveraging New Data for Implementation Planning

After the wake of the initial and then the first extension of the MDR deadline, ...

The Basics of Cybersecurity for Medical Device Manufacturers

Why is cybersecurity such a hot topic in MedTech spaces right now? Learn the ...

QMS from a Regulatory Perspective

Carmen Brown: Regulatory Affairs Manager, Proxima Clinical Research

Design Control 101

Join our partners from Kapstone medical as they discuss the basics and how to ...

Session 3: Monitoring and Data Management (Super users)

Document and Change Management in Greenlight Guru

Document and Change Management Workflows in Greenlight Guru

FDA QSR 21 CFR Part 820 Foundation Training

Following the FDA’s recent QSR remodeling proposal to align the current ...

An Overview of UDI Requirements for MedTech

Gain a high level understanding of UDI requirements and some insight into ...

The Basics of Bill of Materials (BOMs) for MedTech

Trust us, these BOMs are perfectly safe as long as you know what you're doing. ...

Balancing Innovation & Regulation: Navigating Design Development While Keeping Quality and Regulatory in Mind

3 Keys to Successful Internal Audits

Gurus Taylor Brown and Sara Adams discuss their top 3 ways to have better ...

Administration and User Management

Learn about administrator set up and user management within your Greenlight ...

LIVE Guru Workshop: Making the Connection Between Design Control Elements

Hands-on, Guru-led Guru Workshop focusing on how to make connections between ...

Developing a New Clinically Relevant ICU Ventilator Fast

A session by John Walmsley, VP of Strategic Partnerships at Starfish Medical

A Complete Guide to 21 CFR Part 11

In this comprehensive guide, we’ll take you through each section of 21 CFR Part ...

3 Keys to Document Management Success within Greenlight Guru

Join Guru Jesseca Lyons as she walks through 3 keys to success for the Document ...

How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device

A session by Mike Baca, President at White Rook Consulting

CE Mark Technical Documentation: Changes, Application, and Notified Body Expectations under MDR

This presentation will provide an overview of the technical documentation ...

An Overview of Risk Management

Learn about risk management for medical devices.

A Step-By-Step Guide to Determine how your Medical Device will be Classified

In this guide, I will provide you with a step-by-step approach for determining ...

How to Embrace Risk for Safer Devices

Check out one of our favorite podcast episodes from the Global Medical Device ...

A Step-By-Step Guide to Preparing your FDA 510(k) Submission

Get ready to submit your 510(k) with advice from our industry experts

FDA 510(k) Overview

Get to know this common FDA clearance path and understand when you'll need to ...

Building the Business Case

Learn why it's important to be able to articulate your business plan and some ...

Design Controls in Greenlight Guru

Learn the Design Controls Workflow in Greenlight Guru from our medical device ...

3 Keys to Success for Projects and Design Controls within Greenlight Guru

Join Guru Jesseca Lyons as she walks through 3 keys to success for using ...

Effective Post-market Surveillance in the EU under MDR

Check out this engaging discussion if you are looking to know more about how ...

Building a Regulatory Strategy Executive Summary

A session by Mike Drues Ph.D., President at Vascular Sciences

From Idea to Product: How to Overcome Execution Gaps and Reach Market Success

Greenlight Guru founder Jon Speer leads a panel of GG customers in a discussion ...

eMDR Program and Process

Alireza Hemmati: Senior Product Assessment, TÜV SÜD

🚨 Special Discount🚨 on EU IVDR 2017 746 Practitioner

This EU IVDR 2017 746 Practitioner Course provides an in-depth foundation on ...

🚨 Special Discount🚨 on ISO 13485 Lead Auditor Training

Ideal for anyone that has a good understanding of Quality Management Systems ...

Audit Basics

Learn the difference between audits, inspections, and the different types of ...

ISO 9001 (2015) Foundations Training

Our Online ISO 9001 Foundation eLearning is ideal for anyone looking to gain a ...

The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in 2023

A Talk by Carlos Almeida, Amanda Feddersen, Weronika Michaluk and David Shanes: ...

Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device

When you want to know more about biocompatibility, you go to the experts! Hear ...

How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns

A session by Mary McNamara-Cullinane. Senior Vice President of Regulatory ...

How Risk Management Can Help Drive Innovation

A session by Michael Quinn, Vice President of Design and Engineering at HS ...

MDSAP Foundation Training

Our Online MDSAP eLearning Course aims to provide learners with the knowledge ...

Modernizing your QMS to keep up with the Modern Age of Requirements

Ben Bancroft and Radhika Pandya: Greenlight Guru

How Electronic Data Capture Is Transforming the MedTech Industry

A Talk by Jon Bergsteinsson, Autumn Dawn Lang PhD, RAC and Rianne Tooten: ...

AMA on Quality Communication

A conversation with Lesley Worthington, J.D. about best practices for ...

The ROI of Shifting Mindset From Compliance to Quality

A Talk by Edwin Chung, Aaron Gifford, Daniel Powell and Jeff Schwegman: SPK and ...

Leveraging Modern Software Technologies: MedTech’s Best Kept Secret

A Talk by Damini Agarwal, Som Pathak, Michael Roberts and Maxime Rochon: ...

True Quality Roadshow 2023: Houston, Texas

Join the Greenlight Guru team, Velentium, and Houston's top medical device ...

3 Keys to Risk Management Success in Greenlight Guru

Join Guru Jesseca Lyons as she walks through 3 keys to success for the Risk ...

An Overview of Document Management

Learn what Document Management is and why it is so important in the medical ...

🚨 Special Discount🚨 on ISO 9001 Lead Auditor Training

The Online ISO 9001 Lead Auditor Training is ideal for anyone that has a good ...

Guru Workshop Recordings

Addressing the Notified Body Bottleneck

This presentation explores the current state of notified body designation and ...

From Concept to Commercialization

So you have an idea for a medical device...what now? This course gives a quick ...

Applying a Risk-Based Approach to Biological Evaluation of Medical Devices Based on the Framework of ISO 10993-1:2018

What does ISO 10993 require and what are some best practices when applying risk ...

QMSR Harmonization: The Future of FDA's Quality Management System Regulation

A talk by Dr. Deepa Pandia: NAM Auditing Department Manager, TÜV SÜD

Moving up to the State of the Art in Risk Management

Ed Bills: ASQ Fellow, RAC, Consultant: Edwin Bills Consulting

Design Control 101 for Software as a Medical Device (SaMD)

Medical Device Gurus Wade Schroeder and Laura Court share best practices for ...

15 Steps to Creating a Risk-Based CAPA Process

This PDF and infographic will have you implementing risk in your CAPA process ...

Computer Software Assurance (CSA): Understanding the FDA's New Draft Guidance

Francisco Vincenty: Case for Quality Program Manager, FDA

An Overview of Human Factors Engineering for MedTech

Usability engineering is so important to medical device safety and efficacy, ...

Challenges with Applying Risk Management Throughout the Manufacturing Process

Every medical device developer has to understand risk management. You could ...

CAPA Report Template for the Medical Device Industry

Use this template to complete your CAPA reports as a part of your QMS

Design Control 101 within Greenlight Guru

Documenting the design of a safe product fuels the performance and success of ...

Economic Operators: Implementation Challenges and Opportunities

Learn about the changing responsibilities for Economic Operators in the medical ...

An Overview of Design Controls

What are Design Controls? What do the various regulations require in regards to ...

Behind the Stats: 2022 Medical Device Product Development & Quality Management Benchmark Survey

Learn more about our annual survey and the results we've seen from this years ...

Common Misconceptions on Medical Device Risk & Design Controls

A talk by Rob MacCuspie: Quality and Regulatory Manager, Proxima Clinical ...

A Complete Guide to Bringing a Medical Device to Market

A complete guide for medical device manufacturers looking for guidance on how ...

An Overview of Biocompatibility for Medical Devices

Do all devices need to worry about biocompatibility? What does this topic ...

Greenlight Guru Partner Training

Learn about Greenlight Guru and our customers to better understand the value we ...

LIVE Guru Workshop: Making your List and Checking it Twice

Hands-on, Guru-led Guru Workshop focusing on how to document Design Controls

How to Create Medical Device Labels per EU MDR

A session by Monir El Azzouzi, Founder and CEO at Easy Medical Device

ISO 13485: What's Next?

Chandler Thames: Director of Quality, Rook Quality Systems

Everyone Knows: Training Management [Customer Panel]

Finding the time to migrate your current training system to GG and the benefits ...

By Design: Reduce Risk and Improve Compliance with a Layered Software Architecture

A session by Cynthia Smith, Senior Medical Project Manager at ICS

Customer Feedback and Complaint Form Template

Use this template to document customer feedback and complaints in your QMS.

Change Management and Risk Management: How do we connect the dots and what happens if we don't?

Change management and risk management should work together, but it does take ...

How and When to Conduct your First Hazard Analysis

A session by Sarah Nixon, Quality Engineer with Rook Quality Systems

Essentials of Software as a Medical Device

With software being a growing industry, in general, it is no surprise that this ...

ISO 13485 (2016) Internal Auditor Training

Our Online ISO 13485 Internal Auditor Training Course is ideal for anyone that ...

Biocompatibility Evaluation for Device Submission

Learn about the requirements for biocompatibility evaluation testing and some ...

Design Controls, Development, and Risk for SaMD

Many elements of medical device development are different for software devices. ...

Documenting Risk Management to Meet Requirements of ISO 14971:2019

A session by Edwin Bills, Consultant

Europe's First Device Regulations: A Look Into Manufacturers' Response to the Delay, Transition, & Implementation Process

Jon Speer, Founder of Greenlight Guru, will dive into key data and findings ...

How to Efficiently Document your Design Transfer to Ace your Audit and Product Launch

A session by Kyle Rose, President at Rook Quality Systems

3 Systems of Risk for Medical Devices

Learn about the 3 systems of risk the FDA may use when evaluating your device ...

From Self-Declaration to Certification: Proving Performance Under IVDR

Learn best practices around proving performance under the new IVDR requirements.

How to Integrate Risk Management Throughout the Lifecycle of a Medical Device

Join Greenlight Guru Founder, Jon Speer, as he discusses the next decade of ...

Introducing: Greenlight Guru Academy Advance

A dedicated subscription-based learning platform built for you to advance – your skills, your team, your device, and more. With Advance, learners will receive twice as much content, exclusive badges, thoughtfully curated learning paths, and easier ways to get professional certifications

Advance Your Career
  • Curated Success Paths to guide you through your MedTech journey
  • Badges and credentials that will become the MedTech industry standard and bring more credibility to your company
  • Professional certifications that can be bundled with your plan
  • Unlock member-only VIP events to elevate your learning with other members of the MedTech industry
Advance Your Team
  • Teams of 3+ learners can be managed together in GG Academy
  • Dashboards to monitor team completion and progress
  • Onboarding new team members? Add them to your Academy team and watch them level up and add value quickly
  • Volume discounts as your team grows
Advance Your Device
  • Live seminars provide new learning opportunities for top industry topics
  • Deep Dive: only Advance members get our full lineup of MedTech Lifecycle content
  • 100 new on-demand courses for members only
  • Exclusive Community for peer-to-peer learning and discussion
  • Industry best-practices and actionable training from industry experts
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Who is a Greenlight Guru Academy Advance membership for?

  • MedTech professionals looking to start or grow their career. Whether you are a student, recent grad, or transitioning from a different industry, we can help you get up to speed quickly.
  • Leaders who need to level up their medical device teams. Grow your business with the necessary education to design, develop and market safe and effective medical devices.
  • Industry veterans who know the challenges of MedTech and need help keeping up. Things change quickly, so you can't rely on what you already know. Fit professional development into your busy schedule with GG Academy.

Advance Membership

Many items at GG Academy will always be free, but if you want to advance your MedTech learning these memberships are for you.

Advance
$500/year For less than $50 a month, you'll unlock exclusive Advance content, events, and more! You can even manage groups of 3 or more with a special dashboard that gives access to analytics and completion certificates for your team.
Buy Now
Features
  • Check 200+ pieces of content
  • Check Success paths and badges
  • Check VIP community room
  • Check Members-only events
  • Check Templates, checklists, and guides
Premium
$1200/year All that amazing, exclusive content we just mentioned in the Advance membership, plus two premium certifications of your choice. Users who bundle certifications save an average of $250 over buying them individually without a membership!
Buy Now
Features
  • Check 200+ pieces of content
  • Check Success paths and badges
  • Check VIP community room
  • Check Members-only events
  • Check Templates, checklists, and guides
  • Check 2 premium certifications included ($900 value!)
Unlimited
$2000/year For the medical device professional who refuses to be held back, this plan LITERALLY gets you everything the Academy has to offer! That's everything listed so far plus 10 professional certifications and counting. How much learning can you fit into 12 months? Let's find out!
Buy Now
Features
  • Check 200+ pieces of content
  • Check Success paths and badges
  • Check VIP community room
  • Check Members-only events
  • Check Templates, checklists, and guides
  • Check Unlimited premium certifications ($4500 value!)

Frequently Asked Questions

Who is Greenlight Guru Academy for?

Greenlight Guru Academy is open to all individuals interested or pursuing a career in the medical device industry.

Our courses and certifications are geared toward product development, quality, and regulatory professionals that want to enhance their knowledge and stay up-to-date with industry regulations by earning the credentials that drive growth and success.

As Greenlight Guru’s official learning resource, Greenlight Guru Academy also aims to educate users on the Greenlight Guru software platform, so they can design, develop and market safe and effective medical devices — but is not exclusive to Greenlight Guru customers.

How do I enroll in Greenlight Guru Academy?

Get started in Greenlight Guru Academy in 3 easy steps:
  1. Go to www.academy.greenlight.guru
  2. Use code: EXPLORE_ENGAGE_EDUCATE to enroll for free
  3. Create your free account

Once you are in you will be able to personalize your account, take a tour of Greenlight Guru Academy, and enroll in your first course!

When you sign up for Greenlight Guru Academy, you get access to online education resources, flexible courses, and certifications to help you improve your industry knowledge and grow your business.


Many of our courses are free and available on-demand, but premium content and certifications are available for purchase.

Who teaches the courses?

Our content is created and delivered by experts in and outside of Greenlight Guru. Our internal Guru team compiles their years of experience and knowledge to curate courses that guide you through the basics and best practices for operating in the medical device industry.

We also work with our extensive partner network to bring you the latest and most relevant content in the industry.

How can I provide feedback or suggest new courses?

Reach out to us! If you have feedback or course suggestions, complete the form that appears when you finish a course or reply to our email. We are always studying new material to cover that will help you excel at your job and continue to bring life-changing medical devices to market.

Why should I earn and show off my Greenlight Guru badges and certifications?

Being a Greenlight Guru certified professional is something to be proud of! Greenlight Guru Academy badges and certifications are unique, verifiable credentials that validate your knowledge of the Greenlight Guru Platform and medical device industry topics and regulations.

Earn it and share it with the world to advance your career and grow your business!

My company uses Greenlight Guru. Can we add GGA Advance subscriptions to our existing contract?

You can! Contact your Customer Success Manager to discuss options and discounts available.

Built for Learners
Like You

Establishing a QMS
Culture of Quality
Impress Auditors
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Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission.

Ryan Nolan Co-Founder / VP of Clinical Operations Photonicare
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Greenlight Guru was instrumental in implementing our Quality System. With them, we can bring safer, higher-quality medical devices to success while maintaining a Quality Culture throughout our entire device lifecycle.

Maxime Rochan Director of Quality Puzzle Medical
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Greenlight Guru has differentiated us from other start-ups. Our auditors told us, "Wow, you're steps ahead of anyone else."

Amy Papranec VP of Clinical Operations Critical Care Diagnostics, Inc.