Mastering Safety Risk Management for Medical and In Vitro Devices
eBook - ePub

Mastering Safety Risk Management for Medical and In Vitro Devices

  1. 304 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Mastering Safety Risk Management for Medical and In Vitro Devices

About this book

When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product's life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485: 2016, ISO 14971: 2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).

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Yes, you can access Mastering Safety Risk Management for Medical and In Vitro Devices by Jayet Moon,Arun Mathew in PDF and/or ePUB format, as well as other popular books in Business & Auditing. We have over one million books available in our catalogue for you to explore.

Information

Publisher
ASQ Quality Press
Year
2024
Print ISBN
9781636941707
eBook ISBN
9781636941721
Topic
Business
Subtopic
Auditing
Index
Business

Table of contents

  1. Author Acknowledgments
  2. Chapter 1 How to Use This Book: From Risk to Benefit
  3. Chapter 2 ISO 14971:2019 and the Definition of Risk
  4. Chapter 3 Overview of the Risk Management Process
  5. Chapter 4 The Risk Management Process — ISO 14971:2019
  6. Chapter 5 Risk Response and Residual Risk Planning
  7. Chapter 6 Risk, Design Controls, and Design Assurance
  8. Chapter 7 Risk Management Plan and Risk Management Report
  9. Chapter 8 An Introduction to Hazard Theory of Risk Management
  10. Chapter 9 A Deep Dive Into ISO 14971:2019
  11. Chapter 10 Hazard Analysis: Preliminary and Comprehensive
  12. Chapter 11 Risk Evaluation and Risk Acceptability Criteria
  13. Chapter 12 Understanding the Probability of Occurrence and Severity
  14. Chapter 13 Failure Modes and Effects Analysis (FMEA)
  15. Chapter 14 Fault Tree Analysis (FTA)
  16. Chapter 15 Event Tree Analysis (ETA): Probabilistic Risk Analysis
  17. Chapter 16 Production Process Risk Management
  18. Chapter 17 Usability Risk Management
  19. Chapter 18 FDA QMSR Interactions Between ISO 13485 and ISO 14971
  20. Chapter 19 Software Risk Management
  21. Chapter 20 Post-Market Surveillance and Risk Management
  22. Chapter 21 Principles of a Robust and Comprehensive Benefit-Risk Assessment
  23. Appendix
  24. Endnotes