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Mastering Safety Risk Management for Medical and in Vitro Devices / Jayet Moon and Arun Mathew.
- Format:
- Book
- Author/Creator:
- Moon, Jayet, 1988- author.
- Mathew, Arun, 1982- author.
- Language:
- English
- Subjects (All):
- Medical instruments and apparatus--Safety measures.
- Medical instruments and apparatus.
- Prenatal care.
- Physical Description:
- 1 online resource (305 pages)
- Edition:
- First edition.
- Place of Publication:
- Milwaukee, WI : Quality Press, [2024]
- Summary:
- 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).
- Contents:
- Cover
- Table of Contents
- Author Acknowledgments
- Chapter 1 How to Use This Book: From Risk to Benefit
- Chapter 2 ISO 14971:2019 and the Definition of Risk
- Chapter 3 Overview of the Risk Management Process
- Chapter 4 The Risk Management Process - ISO 14971:2019
- Risk Analysis and Estimation
- Risk Evaluation
- Risk Control
- Chapter 5 Risk Response and Residual Risk Planning
- The Concept of Secondary Risk
- The Concept of Residual Risk
- Chapter 6 Risk, Design Controls, and Design Assurance
- Chapter 7 Risk Management Plan and Risk Management Report
- Risk Management Plan (RMP)
- Risk Management Report (RMR)
- Chapter 8 An Introduction to Hazard Theory of Risk Management.
- Chapter 9 A Deep Dive Into ISO 14971:2019
- The Hazard
- Hazardous Situation
- Faults, Errors, and Failures
- Sequences or Combinations of Events
- Pulling It All Together: Hazard-Hazardous Situation, Harm Trifecta
- Chapter 10 Hazard Analysis: Preliminary and Comprehensive
- Preliminary Hazard Analysis (PHA)
- Comprehensive Hazard Analysis
- Chapter 11 Risk Evaluation and Risk Acceptability Criteria
- Establishing a Risk Policy
- Approaches To Risk Acceptability
- Chapter 12 Understanding the Probability of Occurrence and Severity
- Probability: A Mathematical Approach
- Use of Inferential Statistics
- Chapter 13 Failure Modes and Effects Analysis (FMEA)
- Workflow for UFMEA or Application FMEA (AFMEA)
- Chapter 14 Fault Tree Analysis (FTA)
- Risk Analysis Using FTA
- Chapter 15 Event Tree Analysis (ETA): Probabilistic Risk Analysis
- Chapter 16 Production Process Risk Management
- Process Control Plans (PCP)
- Hazard Analysis and pFMEA
- Utilizing Statistics
- p1 and p2 Assessment
- Verification of Implementation and Verification of Effectiveness
- ISO 14971 Expectations
- Chapter 17 Usability Risk Management.
- Formative and Summative Evaluations
- Acceptance Criteria
- Use Error Types and Risk Controls
- Use-Related Risk Analysis (URRA)
- Chapter 18 FDA QMSR Interactions Between ISO 13485 and ISO 14971
- Introduction to QMSR
- Evolution of the Standards and Regulations
- Interactions Between ISO 13485 and 14971
- General Requirements
- Design and Development
- Manufacturing
- Post-Production
- Commentary
- Chapter 19 Software Risk Management
- Spatial Considerations
- Regulatory Scope
- Software Risk Management Methodology
- Closing Thoughts
- Chapter 20 Post-Market Surveillance and Risk Management
- Role of Risk Management in Post-Market Surveillance (PMS)
- Cross-Functional Interface
- Strengthening Risk Management with Post-Market Data
- Reacting to Complaint Data
- Analysis and Trend Detection
- Post-Market Risk Monitoring
- What Are Trigger Conditions and Why Should They Be Monitored?
- Statistical Trending Methods
- Trend Is Triggered: What Is Next?
- Post-Market Surveillance Reports and Periodic Safety Update Reports
- Chapter 21 Principles of a Robust and Comprehensive Benefit-Risk Assessment
- Defining Risks and Benefits
- Assessing the Benefit-Risk Profile
- Benefit-Risk Assessments Throughout the Device Life Cycle
- Appendix
- Endnotes.
- Notes:
- Description based on publisher supplied metadata and other sources.
- Description based on print version record.
- ISBN:
- 1-63694-171-0
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