Page 20 - Safety Risk Management for Medical Devices

PREFACE

A writer is, after all, only half his book. The other half is the reader and from the reader the
writer learns.
P.L. Travers, author (1899 1996)

This book is written to serve both the professionals in the MedTech industry as well
as the students in universities. The book delivers not only the theory but also offers
practical guidance on how to apply the theory in your day-to-day work. The objec-
tive of this book is to demystify risk management and provide clarity of thought and
confidence to the practitioners of risk management as they do their work.
I offer here the result of 30 1 years of experience in risk management beginning
with my work on the Space Shuttle at NASA and continuing in the medical device
industry. What is presented in this book is the best available knowledge today. But as
in any scientific or technical endeavor, the methods and techniques in risk manage-
ment will continue to evolve, mature, and improve.
Although I serve the Medtronic corporation, the opinions and materials presented
in this book are mine and do not represent the Medtronic corporation.

Bijan Elahi

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