Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices

1st Edition - June 29, 2018

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  • Author: Bijan Elahi
  • eBook ISBN: 9780128130995
  • Paperback ISBN: 9780128130988

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Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle the difficult questions, such as how to define risk acceptance criteria and how to determine when to stop risk reduction. This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971—a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of the-art methodologies that are rooted in current industry best practices. Opening chapters introduce the concept of risk, the legal basis for risk management, and the requirements for a compliant risk-management process. The next group of chapters discusses the connection between risk management and quality systems, usability engineering and biocompatibility. This book delves into the techniques of risk management, such as fault tree analysis and failure modes and effects analysis, and continues with risk estimation, risk control, and risk evaluation. Special topics such as software risk management, clinical investigations, and security are also discussed. The latter chapters address benefit-risk analysis, and production and postproduction monitoring. This book concludes with advice and wisdom for sensible, efficient, and successful safety risk management of medical devices.

Key Features

  • Teaches industry best practices on medical-device risk management in compliance with ISO 14971
  • Provides practical, easy-to-understand, and step-by-step instructions on how to perform hazard analysis and manage the risks of medical devices
  • Offers a worked-out example applying the risk management process on a hypothetical device


Engineers and other professionals in the MedTech sector who need to know about safety risk management (including design engineers, product engineers, development engineers, software engineers); Quality assurance and regulatory affairs staff in medical device companies; Graduate level biomedical engineering students with an interest in medical devices

Table of Contents

  • 1. Why do risk management?
    2. Fundamentals of risk management
    3. Understanding risk
    4. Risk Management standards
    5. Requirements of a compliant risk management process
    6. Quality management system
    7. Usability engineering and risk management
    8. Biocompatibility and risk management
    9. Risk management process
    10. Risk analysis techniques
    11. Safety vs. reliability
    12. Influence of security on safety
    13. Software risk management
    14. Integration of risk analyses
    15. Risk estimation
    16. Risk controls
    17. Risk evaluation
    18. Risk assessment and control table
    19. On testing
    20. Verification of risk controls
    21. Benefit-risk analysis
    22. Production and post-production monitoring
    23. Traceability
    24. Risk management for clinical investigations
    25. Risk management for legacy devices
    26. Relationship between ISO 14971 and other safety standards
    27. Risk management process metrics
    28. Risk management and product development process
    29. Critical thinking and risk management
    30. Advice and wisdom

Product details

  • No. of pages: 424
  • Language: English
  • Copyright: © Academic Press 2018
  • Published: June 29, 2018
  • Imprint: Academic Press
  • eBook ISBN: 9780128130995
  • Paperback ISBN: 9780128130988

About the Author

Bijan Elahi

Bijan Elahi is an expert on a world scale in safety risk management for medical technology. Mr. Elahi’s mission is to elevate knowledge and proficiency in medical device risk management to the highest levels worldwide via teaching, coaching, and mentoring, for the benefit of companies and society. He has 30+ years of experience in risk management, working with the largest medical device companies in the world, as well as with small start-ups. He is a lecturer at Eindhoven University of Technology (the Netherlands), where he teaches a graduate-level course in medical device risk management. The audience for this education is doctoral students in engineering as well as physicians and professionals in the medical device sector. Additionally, Mr. Elahi is a lecturer at Drexel University in Philadelphia (USA), and at Delft University of Technology (Netherlands). He is the recipient of the Educator of the Year Award by the International System Safety Society. In 2019 he received an award in recognition of Outstanding Development of Analytical Methods to Support Medical Device System Safety. Mr. Elahi has a long history of medical device development spanning class III implantable pulse generators, electro-mechanical, and disposable devices. His most recent product was a Deep Brain Stimulator (DBS) implant for Parkinson’s disease. The knowledge that he imparts in his book is rooted in state-of-the-art practical knowledge in medical device development. Mr. Elahi is a Technical Fellow and a corporate advisor at Medtronic. In this role, he teaches and consults on medical device risk management to all Medtronic business units worldwide, including China, India, Middle East, Europe and North America. Mr. Elahi is a contributor to ISO 14971, and a member of the Editorial Board of the Journal of System Safety, a publication of the International System Safety Society. Mr. Elahi is a frequently invited speaker and lecturer at international conferences. Earlier in his distinguished career, he was a systems engineer on the Space Shuttle at NASA (USA). Mr. Elahi holds an MS Electrical Engineering degree from the University of Washington and a BS Aerospace Engineering degree from Iowa State University, United States.

Affiliations and Expertise

International Council on Systems Engineering (INCOSE), International System Safety Society (ISSS), European Institute of Innovation and Technology (EIT Health), FL, USA

Ratings and Reviews

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  • Andrew H. Sun May 23 2021

    A practical and comprehensive risk management methodology for medical devices

    I've recently discovered this book and I've been blown away by what an incredibly useful resource it is,  both because of the  clear theoretical descriptions of different aspects of risk management and also the time taken to create a detailed case study which really brings each of the tools into sharp focus. As someone who has spent a number of years working in or with med dev startups I've repeatedly seen the huge amount of time (and trial and error) needed to take what's written in the standards and regulations and derive a practical and logically consistent risk management methodology.  This book provides a comprehensive manual that will both save time and raise the quality of risk management across the board, but particularly in organisations new to medical device development.

  • Heidi Wed Sep 09 2020

    Very good and comprehensive book

    Really helped me to understand the concept of risk management. I really recommend this book to all MedTech people.

  • EmiliaNeto Mon Nov 18 2019

    Great book

    This book talks touches so many details of risk management and provides useful tools the reader can use and adapt according to their needs. It has been very helpful to me so far.

  • C. E. Tue Feb 12 2019

    Design safety of medical devices

    Elsevier Academic Press has recently published a new safety book titled “Safety Risk Management for Medical Devices” written by Bijan Elahi. This book explains how to conduct a risk management program that will show conformance to the FDA safety standards established for medical devices. It describes a safety process as well as some of the tools utilized in the process. Since medical devices are life saving devices they are somewhat safety-critical, requiring a rigorous process to ensure they are safe for public use. This book revolves around ISO Standard 14971, “Medical devices -- Application of risk management to medical devices”. This standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971 are applicable to all stages of the life-cycle of a medical device. Understanding and applying safety standards is a daunting process, particularly if one is not already familiar with the generic System Safety Engineering risk management process. The author presents risk management in a comprehensive and thorough fashion. He provides definitions, interprets unclear sections of the standards, provides templates, and step by step directions on how to perform risk management analysis of complex medical devices. The author also provides special tips to warn about confusing areas and how to avoid problems associated with these areas. The author presents a methodology he has developed called the “BXM” method for conducting a thorough risk management process. This is a complete process that essentially follows the basic tenets of the System Safety Engineering process, thereby following the design-for safety philosophy. He also provides a detailed demonstration of the risk management information discussed in the book through the application of his BXM method on an example system. A sample of some of the topics covered in this book include: • Understanding risk • Requirements of the risk management process • Risk management standards (for medical devices) • Relationship between ISO 14971 and other standards • The BXM method • Risk analysis techniques • Software risk management • Risk estimation • Risk controls • Risk management process management metrics • The BXM method applied to an example (hypothetical) medical device In the chapter on risk analysis techniques the author provides an introduction on how to perform Fault Tree Analysis, Failure Modes and Effects Analysis, Preliminary Hazard Analysis, and Mind Map Analysis. Since these techniques are not trivial the reader might need more detailed information from other sources in order to perform the analysis technique on a large complex system or product. If you work in the medical device field, either in design or safety, this book is a definite required read.