ISO 14971 Risk Management for Medical Devices: The Definitive Guide

In this free ebook, learn how to use risk management as a tool for success.

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The purpose of this guide is three-fold: To leave you with an understanding of what is expected from medical device regulators regarding Risk Management. To help you use Risk Management as a tool to design safer medical devices by providing a few helpful tips and pointers to guide you. To share with you all the steps that you need to define and address within your Risk Management procedures.

In this extensive 43-page ebook, Greenlight Guru provides the definitive risk management guide for medical device companies. You will learn:

  • The importance of risk and medical devices
  • A brief overview of the standards and accompanying guidance
  • The risk management definitions you need to understand
  • How to establish a risk management framework
  • How good design controls reduce product risks
  • The risk management process overview [Infographic Included]
  • What a risk management plan is and what must be included in yours

About the authors: Jon Speer, Founder, and VP of QA/RA at Greenlight Guru