Safety Risk Management for Medical Devices

Couverture
Academic Press, 11 nov. 2021 - 534 pages

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
 

Pages sélectionnées

Table des matières

1 Introduction
1
2 What Is a Medical Device?
5
3 Why Do RiskManagement?
11
4 The Basics
17
5 Understanding Risk
27
6 Risk Management Standards
35
7 Requirements of the Risk Management Process
39
8 Quality Management System
45
26 Traceability
269
27 Lifetime of a Medical Device
271
28 Safety Versus Reliability
273
29 Risk Management for System of Systems
275
30 Risk Management for Clinical Investigations
281
31 Risk Management for Legacy Devices
291
32 Risk Management for Combination Medical Devices
293
33 Basic Safety and Essential Performance
297

9 Usability Engineering and Risk Analysis
47
10 Biocompatibility and Risk Management
59
11 Influence of Security on Safety
63
12 The BXM Method
67
13 Risk Management Process
71
14 Risk Analysis Techniques
89
15 Software Risk Management
155
16 Integration of Risk Analysis
183
17 Risk Estimation
189
18 Risk Controls
199
19 Verification of Risk Controls
207
20 On Testing
213
21 Risk Evaluation
219
22 Risk Assessment and Control Table
225
23 BenefitRisk Analysis
231
24 Risk Management Review
239
25 Production and PostProduction Activities
241
34 Relationship between ISO 14971 and other Standards
299
35 Risk Management Process Metrics
305
36 Risk Management and Product Development Process
307
37 Risk Management for Suppliers
313
38 Axioms
317
39 Special Topics
319
40 Critical Thinking and Risk Management
325
41 Advice and Wisdom
329
Appendix A Glossary
333
Appendix B Templates
339
Appendix C Example Device Vivio
375
Appendix D Useful References
507
References
509
Index
511
Back Cover
516
Droits d'auteur

Autres éditions - Tout afficher

Safety Risk Management for Medical Devices
Bijan Elahi
Aperçu limité - 2018
Safety Risk Management for Medical Devices
Bijan Elahi
Aucun aperçu disponible - 2018
Safety Risk Management for Medical Devices
Bijan Elahi
Aucun aperçu disponible - 2022

Expressions et termes fréquents

2021 Bijan Elahi 2022 Elsevier Ltd action adverse event Assessment Benefit-Risk Analysis Benefits Bijan Elahi Doc BXM method capacitor cause clinical investigation component Copyright 2021 Bijan Countermeasures defib pads defibrillation delivered Described failure mode detecon detection Devices 2022 Elsevier DFMEA document End Effect error example Failure Mode Fault Tree Fault Tree Analysis Fibrillating patient FMEA function Harm Harm.4 Persistent fibrillation Hazardous Situation identify intended Management for Medical manufacturer Medical Devices 2022 Mind Map Mitigations Overall Residual Risk performance PFMEA PMCF Post-Market Surveillance potential probability of occurrence quantitative RACT ranking reduce RPN requirements Revision 1.0 Risk Analysis Risk Controls Risk Estimation Risk Management File Risk Management Plan risk management process risk matrix Safety Impact Safety Risk Management Section SFMEA Software Failure Software Item software safety SSCP standards System level Table template UMFMEA usability engineering Vivio

À propos de l'auteur (2021)

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.

Informations bibliographiques

TitreSafety Risk Management for Medical Devices
AuteurBijan Elahi
Édition2
ÉditeurAcademic Press, 2021
ISBN0323918239, 9780323918237
Longueur534 pages
  
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