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eBooks and Guides

Ultimate Guide to FDA Design Controls for Medical Device Companies

How to start using FDA design controls to your benefit today & implement a process to actual improve your medical device product development efforts.

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

Learn how to implement and maintain a risk-based CAPA process while avoiding the most common pitfalls at your medical device company.

The Risk Management + Design Controls Connection

Everything device makers need to know about the Risk Management + Design Controls connection in medical device product development.

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Webinars

FDA's Case for Quality: What, Why and How? Changing the Regulatory Paradigm

Greenlight Guru has partnered with FDA to give you the inside track on what you need to know about the Case for Quality, the changing regulatory paradigm, and what all this means for all stakeholders involved with the medical device industry.

Bridging User Needs & Design Requirements

A Timeline to Comply with ISO 13485:2016 (And What You Need to Be Doing Today)

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Podcasts

FDA Allows Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

Episode 65

How to Use the Abbreviated FDA 510(K) Pathway to Your Advantage

Episode 64

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not be as Scary as You Think)

Episode 63

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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 nervious going into the audit, because it seemed too effortless."

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In The News
Five Common Mistakes Companies Make With CAPA

Five Common Mistakes Companies Make With CAPA

By Jon Speer

Quality Digest June 20th, 2018

Why the FDA Presubmission Is an Underutilized Tool

Why the FDA Presubmission Is an Underutilized Tool

By Jon Speer

Quality Digest April 30th, 2018

A timeline to adopt medical device QMS (and why you need to act now)

A timeline to adopt medical device QMS (and why you need to act now)

By Jon Speer

MedCity News April, 23rd 2018

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