Safety Risk Management for Medical Devices
Language: English
Published by Elsevier Science Publishing Co Inc, 2018
- Softcover
- Used
Seller: Mooney's bookstore, Den Helder, NetherlandsMooney's bookstore
AbeBooks seller since June 10, 2024
Condition: Used - Very good
£ 57.96
Quantity: 1 available
Add to basketSeller Inventory # C2B6DF9B45E5064
- Title
- Safety Risk Management for Medical Devices
- Author
- Bijan Elahi
- Publisher
- Elsevier Science Publishing Co Inc
- Publication year
- 2018
- Condition
- Very Good
- Binding
- Soft cover
- Language
- English
- ISBN 10
- 0128130989
- ISBN 13
- 9780128130988
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.
- 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
"Synopsis" may belong to another edition of this title.
About the Author
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.
"About the title" may belong to another edition of this title.
Mooney's bookstore
Den Helder, Netherlands
AbeBooks seller since June 10, 2024
Shipping rates from Netherlands to U.S.A.
| Item | 14 to 21 business days | 5 to 10 business days |
|---|---|---|
| First item | £ 12.47 | £ 29.15 |
Payment methods
Specialty
Historical books, Dutch books, Art booksRight of withdrawal
If you are a consumer you can withdraw from the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.
Information regarding the right of withdrawal
Statutory right to withdraw
You have the right to withdraw from this contract within 14 days without giving any reason.
The withdrawal period will expire after 14 days from the day on which you acquire, or a third party other than the carrier and indicated by you acquires, physical possession of the last good or the last lot or piece.
To exercise the right of withdrawal, electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". We will communicate to you an acknowledgement of receipt of such a withdrawal on a durable medium (e.g. by e-mail) without delay.
To meet the withdrawal deadline, it is sufficient for you to send your communication concerning your exercise of the right of withdrawal before the withdrawal period has expired.
Effects of withdrawal
If you withdraw from this contract, we will reimburse to you all payments received from you, including the costs of delivery (except for the supplementary costs arising if you chose a type of delivery other than the least expensive type of standard delivery offered by us).
We may make a deduction from the reimbursement for loss in value of any goods supplied, if the loss is the result of unnecessary handling by you.
We will make the reimbursement without undue delay, and not later than 14 days after the day on which we are informed about your decision to withdraw from this contract.
We will make the reimbursement using the same means of payment as you used for the initial transaction, unless you have expressly agreed otherwise; in any event, you will not incur any fees as a result of such reimbursement.
We may withhold reimbursement until we have received the goods back, or you have supplied evidence of having sent back the goods, whichever is the earliest.
You shall send back the goods or hand them over to Mooney's bookstore, Den Helder, Netherlands, without undue delay and in any event not later than 14 days from the day on which you communicate your withdrawal from this contract to us. The deadline is met if you send back the goods before the period of 14 days has expired. You will have to bear the direct cost of returning the goods. You are only liable for any diminished value of the goods resulting from the handling other than what is necessary to establish the nature, characteristics and functioning of the goods.
Exceptions to the right of withdrawal
The right of withdrawal does not apply to:
- The delivery of newspapers, journals or magazines with the exception of subscription contracts; and
- The supply of digital content which is not supplied on a tangible medium (e.g. on a CD or DVD) if you accepted when you placed your order that we could start to deliver it, and that you could not withdraw once delivery had started.