Page 22 - Safety Risk Management for Medical Devices

CHAPTER 1

Introduction

Abstract
This book is about management of safety risks for medical devices. You will learn how to answer
difficult questions such as: Is my medical device safe enough? What are the safety-critical aspects of
my device, and which are the most important ones? Have I reduced the risks as far as possible? A
sound and properly executed risk management process does not render a risk-free medical device.
It does imply that the best efforts were made to produce a device that is adequately safe—a device
that provides benefits which outweigh its risks.
Keywords: Risk management; medical device

This book is about management of safety risks for medical devices. You will learn
how to answer difficult questions such as: Is my medical device safe enough? What
are the safety-critical aspects of my device, and which are the most important ones?
Have I reduced the risks as far as possible?
One of the main challenges of medical device companies is to be able to tell a
clear and understandable story in their medical device submissions as to why their
medical device is safe enough for commercial use. The methodology offered in this
book, which we call the “BXM method” offers a simple, understandable, and inte-
grated process that is scalable and efficient. The BXM method is suitable for automa-
tion, which is a huge benefit to the practitioners of risk management in an
environment of dynamic and complex medical technology.
The methodology offered in this book is in conformance with ISO 14971, and
has been used and tested numerous times in real products that have been submitted
and approved by the FDA and European notified bodies.
Risk management is a truly interdisciplinary endeavor. A successful risk manager
employs skills from engineering, physics, chemistry, mathematics, logic, behavioral
science, psychology, and communication, to name a few. In this book, we touch
upon ways in which the various disciplines are employed at the service of risk
management.
This book is designed to serve both university students who are neophytes to risk
management, as well as industry professionals who need a reference handbook. An
example of execution of the BXM method on a hypothetical medical device is pro-
vided in Appendix C as a model to further elucidate the BXM method.

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00001-5 All rights reserved. 1