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eBooks and Guides

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Ultimate Guide to Clinical Evaluation of a Medical Device in the EU

A four-part comprehensive guide to help manufacturers understand the essentials of clinical evaluation for medical devices in the European Union (EU).

25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

A comprehensive list of most frequently asked questions and their answers about ISO 15223-1:2021 Fourth Edition, the latest version of the international standard for the application of medical device symbols on labels.

Ultimate Guide to QA & RA in Medical Device 3D Printing

A white paper to guide users in the medical device industry through every stage of the product development process, from evaluating manufacturing methods and 3D printing technologies to specific regulatory requirements, for commercializing and marketing end-use 3D printed medical devices.

The Risk Management + Design Controls Connection: What Device Makers Need to Know

A valuable resource to help medical device manufacturers bridge the connection between design control and risk management processes in order to design, develop, manufacture, and sell the most safe and effective devices.

2021 EU MDR Preparedness Study

In this report, we wanted to provide you with a holistic picture of what other medical device teams are doing to prepare for the upcoming EU MDR deadline and give you a full 60 day action plan to get prepared, regardless of your current state of preparedness. 


State of Medical Device Quality Management and Product Development Report

Understand what today’s medical device professionals are doing or using to accelerate product development, ensure compliance, and promote quality based on original research findings from hundreds of medical device professionals.

Ultimate Guide to Training Management for Medical Device Companies

Comprehensive guide to help medical device companies learn about training management, including compliance requirements and proven ways to promote total competence of the members of a medical device organization.

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

In-depth guide covering the requirements of 21 CFR Part 820, FDA's quality system regulation for medical devices, including tips on how to comply and avoid common pitfalls.

Ultimate Guide to Document Control

In-depth guide for medical device companies on how to control documents and improve procedures, with actionable solutions to common problems with document control activities and methods for implementing a document management system that enables product and business success.

Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices

Learn the most up to date recommendations and best practices from the ISO 14971:2019 standard and how you can start to use risk management as a tool - not a checkbox activity.

Best QMS Software: Ultimate Guide To Comparing Quality Management System Solutions

The best QMS software comparison guide for medical device companies that will help you choose a quality management system solution that strategically benefits your product and company.

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

Know what questions to ask software vendors that give your medical device company the necessary information to consider when selecting a QMS software solution.

Definitive Guide to Change Management for Medical Devices

A definitive guide on change management best practices to help medical device companies understand and manage changes to documents, products, processes and more.

5 Do's And Don'ts When Choosing A Qms Solution For Your Medical Device Company

A guide to the top 5 recommended best practices that medical device companies should consider when choosing a quality management system (QMS) solution.

A Complete Guide to Bringing a Medical Device to Market

A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global markets.

Ultimate Guide To Agile Design And Development For Medical Devices

In-depth overview of Agile design and development processes to improve risk and quality management of medical devices that fulfill user and business needs.

The Essential Guide to Preparing Your QMS for EU MDR

This is the essential guide to help you prepare your Quality Management System (QMS) for the new EU MDR before the transition period ends on May 26, 2020.

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.

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.

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.