Bijan Elahi

Safety Risk Management for Medical Devices (eBook, ePUB)

• Format: ePub

Produktbeschreibung

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

---

Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, B, BG, CY, CZ, D, DK, EW, E, FIN, F, GR, HR, H, IRL, I, LT, L, LR, M, NL, PL, P, R, S, SLO, SK ausgeliefert werden.

Produktdetails

• Verlag: Elsevier Science & Techn.
• Seitenzahl: 534
• Erscheinungstermin: 11. November 2021
• Englisch
• ISBN-13: 9780323918237
• Artikelnr.: 62938342

Autorenporträt

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.

Inhaltsangabe

1 Introduction
2 What Is A Medical Device?
3 Why Do Risk-Management?
4 The Basics
5 Understanding Risk
6 Risk Management Standards
7 Requirements of the Risk Management Process
8 Quality Management System
9 Usability Engineering and Risk Analysis
10 Biocompatibility and Risk Management
11 Influence of Security on Safety
12 The BXM Method
13 Risk Management Process
14 Risk Analysis Techniques
15 Software Risk Management
16 Integration of Risk Analysis
17 Risk Estimation
18 Risk Controls
19 Verification of Risk Controls
20 On Testing
21 Risk Evaluation
22 Risk Assessment and Control Table (RACT)
23 Benefit-Risk Analysis
24 Risk Management Review
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
35 Risk Management Process Metrics
36 Risk Management and Product Development Process
37 Risk Management for Suppliers
38 Axioms
39 Special Topics
40 Critical Thinking and Risk Management
41 Advice and Wisdom
Appendix A - Glossary
Appendix B - Templates
Appendix C - Example Device - Vivio
Appendix D - Useful References