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eBooks and Guides

15 Reasons Medical Device Companies Choose Greenlight Guru

This eBook provides 15 reasons you need a solution such as Greenlight Guru that provides built-in compliance, provides traceability, takes little time to implement, and is augmented by experts with more than a decade in the medical device industry.

21 CFR Part 11: A Complete Guide

We'll take you through each section of 21 CFR Part 11, FDA's regulation for electronic documentation and electronic signatures. We'll explain what the requirements actually mean and expound the most important points for you to know as a medical device company.

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

Learn how to manage all the changes to your medical device QMS to comply with the new regulations & standards; EU MDR, EU IVDR & ISO 13485:2016.

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UX for Medical Devices: Designing for the Evolving Environment of Technology, Safety, Regulation and Recalls

A free webinar on the ways in which UX design can mitigate human error while reducing both recalls and product development costs.

How to Avoid Common Problems with your Design, Risk, and Validation Documentation

A free webinar on the simple ways you and your team can learn to integrate documentation best practices so you can mitigate risk and systemic issues.

Prepping your QMS for EU MDR

A free webinar on the critical steps that are needed in order to prepare your Quality Management System (QMS) for the upcoming EU Medical Device Regulations (EU MDR) in 2020.

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Global Medical Device Podcast

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

Episode 98

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

Episode 97

Nonbinding Feedback is a New Guidance You Should Know About

Episode 96

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MedTech True Quality Stories Podcast

Improving the Quality of Life in the Most Delicate Patient Group: Preterm Infants

Amir Fassihi, M.D.

Founder and CEO, Amnion Life

How Sonavex went from Concept to FDA Clearance in Just 3 Years

David Narrow

CEO, Sonavex

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Case Studies

How Innovere Has Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device Specific eQMS

"With Greenlight Guru, you've got software, but also what amounts to a personal consultant. Those connections are powerful."

Lucerno Dynamics Has Simplified the ISO 13485:2016 Certification Process with Greenlight Guru

"I highly recommend Greenlight Guru. They have taken a complex industry and made it into a product that’s simple to use.”

How Greenlight Guru is Laying the Foundation for Success at Amnion Life

“Greenlight Guru was essential for us to establish a strong foundation for success.”

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In The News
The Most Common Problems With Your CAPA Process

The Most Common Problems With Your CAPA Process

By Jon Speer

Quality Digest, March 25th, 2019

What To Expect During an FDA QSIT Inspection

What To Expect During an FDA QSIT Inspection

By Jon Speer

Quality Digest, March 19th, 2019

Creating an It Factor Culture

Creating an It Factor Culture

By David Deram

The Sales Evangelist, December 7th, 2018

View All Articles