دانلود کتاب Risk Management for Medical Device Manufacturers

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Cover
Title page
CIP data
Contents
List of Figures and Tables
Dedication
Acknowledgments
Preface
List of Abbreviations
Section 1_Building a Risk Program
Chapter 1_The Scope of Risk Management
Chapter 2_What is “Risk”?
Chapter 3_The Sequence of Events—What to Measure
Chapter 4_Control and Monitoring of the Sequence of Events
Chapter 5_How to Define Occurrence Criteria in the RMP
Chapter 6_How to Define Severity Criteria—A Master Harms List
Chapter 7_Establishing Design Inputs and Process Controls
Chapter 8_Risk Analysis and Evaluation
Section 2_Risk in Verification/Validation
Chapter 9_Determining What’s Critical to Quality
Chapter 10_AQL or LTPD?
Chapter 11_Confidence
Chapter 12_Reliability
Chapter 13_How to Distribute Samples—The Invalid Assumption
Chapter 14_Continued Process Verification
Chapter 15_Test Method Validation
Section 3_Using Risk
Chapter 16_What is the Requirement?
Chapter 17_Risk-Based Decisions Regarding the Need for an Investigation
Chapter 18_Quality System Nonconformities
Section 4_Information for Users/Patients
Chapter 19_Two Types of Information
Chapter 20_Warnings, Precautions, Contraindications, and Adverse Reactions/Events
Chapter 21_Information for Safety and Training
Chapter 22_Residual Risk
Section 5_Other Information
Chapter 23_More Bad Guidance in ISO 14971:2019
Chapter 24_Linking Your FMEAs (NCEAs)
Chapter 25_Overlapping Definitions
Chapter 26_Quality Data for Post-Market Surveillance
Chapter 27_Why Investigations Are Illegal in a Nonconformance Report (NCR)
Chapter 28_Don’t Blame the People
Chapter 29_Flowcharts
Summary of Key Takeaways
Checklist of Questions
Bibliography
Index
About the Author