Safety Risk Management for Medical Devices
Product ID: 365938713
Buy anything from 5,000+ international stores. One checkout price. No surprise fees. Join 2M+ shoppers on Desertcart.
Desertcart purchases this item on your behalf and handles shipping, customs, and support to Spain.
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. 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 Review: Complete step by step approach for implementing effective risk management solutions - The book Safety Risk Management for Medical Devices, beautifully articulates the process of risk management in conformance to ISO 14971. More than just theory, it provides step-by-step instructions on the risk management process. This book is easy to read and offers not just clarity on how to identify and quantify risk, but also gives excellent advice on how to bring real value to the product development process. The provided templates and the complete example of a risk management file in Appendix C is an excellent resource, especially as the file has been reviewed by the FDA (US) and BSI (UK). Review: Well written excellent book - Great reference for anyone in medical device industry
| Best Sellers Rank | #1,656,957 in Books ( See Top 100 in Books ) #232 in Biomedical Engineering #5,651 in Technology (Books) #95,187 in Textbooks (Special Features Stores) |
| Customer Reviews | 4.3 out of 5 stars 16 Reviews |
L**N
Complete step by step approach for implementing effective risk management solutions
The book Safety Risk Management for Medical Devices, beautifully articulates the process of risk management in conformance to ISO 14971. More than just theory, it provides step-by-step instructions on the risk management process. This book is easy to read and offers not just clarity on how to identify and quantify risk, but also gives excellent advice on how to bring real value to the product development process. The provided templates and the complete example of a risk management file in Appendix C is an excellent resource, especially as the file has been reviewed by the FDA (US) and BSI (UK).
E**S
Well written excellent book
Great reference for anyone in medical device industry
K**M
An Excellent Book on Safety Risk Mgmt.
Bijan, I have been reading your book this holiday break, and I can’t start to express my gratitude for writing such an excellent text. As you know, it seldom happens in academia that a textbook is both accessible and readable. Thank you for spending all those lonely hours writing this book. I hope our paths cross again soon.
E**N
A great self-learning tool to get started in safety risk management
I have the first edition of this gem and highly recommend it for any professionals in the medical device space wanting to learn practical methods of applying and implementing the state-of-the-art requirements of product safety risk management. A must have to improve your processes and gain insight into the art and science of risk management!
T**R
Delivered late and damaged
The book itself is okay. Not great, but a good resource. The buying experience was bad. The delivery was several days late after multiple "running late" alerts. Then when it was finally delivered, the book cover had multiple scratches and bends. Has Amzon unlearned how to ship books properly? Sometimes I receive box inside box deliveries for items that are not fragile at all, but it seems that books are now shipped in buble wrap envelopes that create lots of damage during shipping. Maybe we should all go back to our local bookstores if our Amazon book orders will take a week to be delivered anyway and will be damaged. Prime is not worth its cost anymore.
A**R
Comprehensive overview of RM for medical device development
Excellent and indispensable resource for medical device professionals. Bijan Elahi is the master of medical device risk management. Book consists of lots of chapters on specific topics which makes them easy to digest. The language is easy to understand. Lots of pictures. Special chapter on wisdom based on experience and critical thinking. An appendix with all concepts applied to a AED development and all important artefacts.
Trustpilot
2 weeks ago
1 month ago