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eBooks and Guides

ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices

ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices offers industry professionals everything related to the topic. Greenlight Guru eQMS platform automates regulatory compliance with ISO 13485:2016, FDA, ISO 14971, so companies can focus on true quality of devices.

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.

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Webinars

FDA Partners with Greenlight Guru: Case for Quality Webinar Series

Free webinar series presented by FDA Case for Quality Manager Cisco Vincenty in partnership with Greenlight Guru. This four-part webinar series covers the future of FDA's Case for Quality initiative and its benefits to the medical device industry.

The 510k and Substantial Equivalence: Why do so many get it wrong?

5 QMS Elements that must Connect to your Design Control for an Effective, Audit Proof Process

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Podcasts

FDA Plans to Modernize 510(k) - Is the Sky Falling?

Episode 86

Understanding the Blurred Lines Between Consumer Tech and MedTech

Episode 85

Understanding The Differences Between Clearance vs Approval vs Granted

Episode 84

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Case Studies

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X In Two Years

“Not having your Design control or Risk Management can be a $20M hair cut on the valuation of your company. I’ve seen first hand a small company being courted by a bigger company; they send over a form asking about quality system, DC, RM, and if it’s not in place it’s going to cost you a lot of money.”

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

"As a design firm, our ISO 13485 certification is a competitive advantage. Greenlight Guru made getting it easy."

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

"I was actually a little nervous going into the audit, because it seemed too effortless."

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In The News
6 Best Practices for Complying with ISO 13485:2016

6 Best Practices for Complying with ISO 13485:2016

By Jon Speer

Medical Product Outsourcing, October 7th 2018

Why Paper-Based Systems No Longer Make the Cut

Why Paper-Based Systems No Longer Make the Cut

By David DeRam

MedTech Intelligence, October 8th, 2018

5 Tips for Post-Market Medical Device Compliance

5 Tips for Post-Market Medical Device Compliance

By Jon Speer

Medical Design & Outsourcing, September 24th, 2018

View All Articles