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eBooks and Guides

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.

Why Paper-Based Quality Management Systems are No Longer an Option

Paper-based quality management systems are no longer an option. The right quality management software platform can save time, money, and allow you to focus on quality.

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FDA's Case for Quality: Simplifying the regulatory activities (Part 4 of 4)

Quality VS Compliance Metrics & What's Next for FDA's Case for Quality Pilot (Part 3 of 4)

The Pre-Market Approval (PMA): Is it really as bad as so many think?

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15 Highly Effective Habits to Lead Your Organization

Episode 74

How to Embrace Risk for Safer Devices

Episode 73

What you Need to know About FDA's Progressive Programs

Episode 72

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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
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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