eBooks and Guides

Free premium content to help your device company move beyond baseline compliance to true quality

More than 68,000 rely on us for the latest in quality

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.

A Step-by-Step Guide to Preparing Your FDA 510(K) Submission

Looking to submit your FDA 510k? This step by step guide provides step-by-step instructions on preparing an FDA 510(k) submission to gain market clearance.

The Art of Design Inputs and Design Outputs

The art of defining design inputs & design outputs for FDA compliance by medical device manufacturers.

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.

Definitive Guide to Responding to FDA 483 & Warning Letters

If you find yourself in this situation, learn how to respond to FDA 483's & warning lettering (includes a free response template)

Step-by-step Guide to Complying with ISO 13485 & FDA QSR

A step by step guide to complying with ISO 13485 and FDA quality management system requirements for medical device companies.

15 Items Medical Device Startups Need to Address

Here are 15 items medical device startups need to address early on as a best practice to ensuring FDA / ISO regulatory compliance.

Step-by-step Guide to Determine How Your Device Will Be Classified

Greenlight Guru presents a step-by-step guide for determining how your medical device will be classified by U.S. FDA, European Commission, and Health Canada.

Definitive Guide to ISO 14971 Risk Management

Learn what is expected from regulators & how you can start to use risk management as a tool - not a checkbox activity.

Guide to Design Verification and Design Validation

Learn exactly what design verification and design validation are, how they are the same, how they are different, and best practices for medical devices.