Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices

2nd Edition - November 11, 2021

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  • Author: Bijan Elahi
  • eBook ISBN: 9780323918237
  • Paperback ISBN: 9780323857550

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Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations.

Key Features

  • Includes new coverage of ISO 14971:2019, ISO/TR 24971
  • Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management
  • Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation


Engineers and other professionals in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book.

Table of Contents

  • 1 Introduction
    1.1 History of risk Management
    2 What Is A Medical Device?
    3 Why Do Risk‐Management?
    3.1 Legal and Regulatory Requirements 
    3.2 Business Reasons
    3.3 Moral and Ethical Reasons
    4 The Basics
    4.1 Vocabulary of Risk Management
    Reasonably Foreseeable Misuse
    4.2 Hazard Theory
    4.3 System and System Types
    5 Understanding Risk
    5.1 Risk Definitions
    5.2 Types of Risk
    5.3 Contributors to Risk
    5.4 Risk Perception
    5.5 Risk Computation
    6 Risk Management Standards
    6.1 ISO 14971 History and Origins
    6.2 Harmonized Standards
    7 Requirements of the Risk Management Process
    7.1 Risk Management Process
    8 Quality Management System
    9 Usability Engineering and Risk Analysis
    9.1 Key Terms
    9.2 Distinctions
    9.3 User‐Device Interaction Model
    9.4 Use Errors
    9.5 Environmental Factors
    9.6 Design Means to Control Usability Risks
    9.7 Task Analysis
    9.8 Usability and Risk
    10 Biocompatibility and Risk Management
    11 Influence of Security on Safety
    12 The BXM Method
    12.1 System Decomposition
    12.2 Integration
    12.3 Quantitative Risk Estimation
    13 Risk Management Process
    13.1 Management Responsibilities
    13.2 Risk Management File
    13.3 Risk Management Plan
    13.4 Hazard Identification
    13.5 Clinical Hazards List
    13.6 Harms Assessment List
    14 Risk Analysis Techniques
    14.1 Fault Tree Analysis
    14.2 Mind Map Analysis
    14.3 Preliminary Hazard Analysis
    14.3.1 Introduction
    14.3.2 Methodology
    14.4 Failure Modes and Effects Analysis
    14.4.1 Facilitation of FMEAs
    14.4.2 Hierarchical Multi‐Level FMEA
    14.4.3 Failure Theory
    14.4.4 Ground Rules
    14.4.5 Criticality Ranking
    14.4.6 Benefits of FMEA
    14.4.7 FMEA Weaknesses
    14.4.8 Ownership of FMEA
    14.4.9 Deciding When to Perform an FMEA
    14.4.10 Making Your Way Through the FMEA
    14.4.11 Revisiting FMEAs
    14.5 FMEA in the context of Risk Management
    14.6 Design Failure Modes and Effects Analysis (DFMEA)
    14.6.1 DFMEA Workflow
    14.7 Process Failure Modes and Effects Analysis (PFMEA)
    14.7.1 PFMEA Workflow
    14.8 Use/Misuse Failure Modes and Effects Analysis (UMFMEA)
    14.8.1 Distinctions
    14.8.2 Use Specification vs. Intended Use
    14.8.3 UMFMEA Workflow
    14.9 P‐Diagram 
    14.10 Comparison of FTA, FMEA
    15 Software Risk Management
    15.1 Software Types
    15.2 Software Risk Analysis
    15.3 Software FMEA (SFMEA)
    15.4 Software Safety Classification
    15.5 The BXM Method for Software Risk Analysis
    15.6 Risk Management File Additions
    15.7 Risk Controls
    15.8 Legacy Software
    15.9 Software of Unknown Provenance
    15.10 Software Maintenance and Risk Management
    15.11 Software Reliability vs. Software Safety
    15.12 Tips for Developing Safety‐Critical Software
    16 Integration of Risk Analysis
    16.1 Hierarchical Multi‐Level FMEA
    16.2 Integration of Supplier Input into Risk Management
    17 Risk Estimation
    17.1 Qualitative Method
    17.2 Semi‐Quantitative Method
    17.3 Quantitative Method
    17.4 Individual and Overall Residual Risks
    17.5 Pre/Post Risk
    17.6 Risks that Cannot be Estimated
    18 Risk Controls
    18.1 Single‐Fault‐Safe Design
    18.2 Risk Control Option Analysis
    18.3 Distinctions of Risk Control Options
    18.4 Information for Safety as a Risk Control Measure
    18.5 Distinction of Types Information for Safety
    18.6 Sample Risk Controls
    18.7 Risk Controls and Safety Requirements
    18.8 Completeness of Risk Controls
    19 Verification of Risk Controls
    19.1 Verification of Implementation
    19.2 Verification of Effectiveness
    20 On Testing
    20.1 Types of Testing
    20.2 Risk‐Based Sample Size Selection
    20.3 Attribute Testing
    20.4 Variable Testing
    21 Risk Evaluation
    21.1 Application of Risk Acceptance Criteria
    21.1.1 How to Determine the State‐of‐the‐Art
    21.2 Risk Evaluation for Qualitative Method
    21.3 Risk Evaluation for Semi‐Quantitative Method
    21.4 Risk Evaluation for Quantitative Method
    22 Risk Assessment and Control Table (RACT)
    22.1 RACT Workflow
    22.2 Individual and Overall Residual Risks
    22.3 Inherent Risks
    23 Benefit‐Risk Analysis
    23.1 What is a Benefit?
    23.2 Balancing Benefits against Risks
    23.3 Benefit‐Risk Analysis in Clinical Studies
    24 Risk Management Review
    25 Production and Post‐Production Activities
    25.1 Regulatory Basis
    25.2 The Purpose of Post‐Market Activities
    25.3 Post‐Market Risk Management
    25.4 The Elements of Post‐Market Risk Management
    25.4.1 Post‐Market Surveillance
    25.4.2 Post‐Market Clinical Follow‐up (PMCF)
    25.4.3 Complaint Handling and Monitoring
    25.4.4 Post‐Market Risk Management Actions
    25.5 Deliverables of Post‐Market Risk Management
    25.5.1 Summary of Safety and Clinical Performance (SSCP)
    25.5.2 Periodic Safety Update Report (PSUR)
    25.5.3 Post‐Market Surveillance Report (PMSR)
    25.5.4 Manufacturer Incident Report (MIR)
    25.5.5 Medical Device Reporting (MDR)
    25.6 Clinical Evaluation
    25.7 Frequency of Risk Management File Review
    25.8 Feedback to Pre‐Market Risk Management
    25.9 Benefits of Post‐Market Surveillance
    26 Traceability
    27 Lifetime of a Medical Device
    28 Safety versus Reliability
    29 Risk Management for System of Systems
    30 Risk Management for Clinical Investigations
    31 Risk Management for Legacy Devices
    32 Risk Management for Combination Medical Devices
    33 Basic Safety and Essential Performance
    34 Relationship between ISO 14971 and other Standards
    34.1 Interaction with IEC 60601‐1
    34.2 Interaction with ISO 10993‐1
    34.3 Interaction with IEC 62366
    34.4 Interaction with ISO 14155
    35 Risk Management Process Metrics
    36 Risk Management and Product Development Process
    36.1 Identification of Essential Design Outputs
    36.2 Lifecycle Relevance of Risk Management
    37 Risk Management for Suppliers
    37.1 Manufacturer Perspective
    37.2 Supplier Perspective
    38 Axioms
    39 Special Topics
    39.1 The conundrum
    39.2 Cassandras
    39.3 Personal Liability
    39.4 Creating a Safety Culture
    39.5 Predicting the Future
    40 Critical Thinking and Risk Management
    41 Advice and Wisdom
    Appendix A ‐ Glossary
    Appendix B – Templates
    B.1 DFMEA Template
    B.2 SFMEA Template
    B.3 PFMEA Template
    B.4 UMFMEA Template
    B.5 RACT Template
    Appendix C – Example Device – Vivio
    C.1 Vivio Product Description
    C.2 Vivio Product Requirements
    C.3 Vivio Architecture
    C.4 Risk Management Plan
    C.5 Clinical Hazards List
    C.6 Harms Assessment List
    C.7 Preliminary Hazard Analysis
    C.8 Design Failure Modes and Effects Analysis (DFMEA)
    C.9 Process Failure Modes and Effect Analysis (PFMEA)
    C.10 Use/Misuse Failure Modes and Effects Analysis (UMFMEA)
    C.11 Risk Assessment and Controls Table (RACT)
    C.12 Full Body Report
    C.13 Risk Management Report
    Appendix D – Useful References


Product details

  • No. of pages: 534
  • Language: English
  • Copyright: © Academic Press 2021
  • Published: November 11, 2021
  • Imprint: Academic Press
  • eBook ISBN: 9780323918237
  • Paperback ISBN: 9780323857550

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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  • Shashank P. Thu Jul 14 2022

    An extremely informative book on Risk Management of Medical devices

    I have 5 years of experience and after read this book it climbed 15 year. Successfully implemented Risk mangement process in my organization. Thank you so much Bijan for writing this!! Must read for all the MedTech peoples