
Safety Risk Management for Medical Devices
Description
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
Readership
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
About the Author
Bijan Elahi
Affiliations and Expertise
Ratings and Reviews
Latest reviews
(Total rating for all reviews)
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.