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Table of Contents Foreword Notes to the Reader Acknowledgments Body of Knowledge Section 1 U.S. Base Law and Regulations Chapter 1 Base U.S. Law Chapter 2 U.S. Regulation Chapter 3 Labeling Chapter 4 Medical Device Reporting Chapter 5 Recalls, Corrections, and Removals Chapter 6 Establishment Registration and Listing Chapter 7 Device Tracking Chapter 8 Electronics Records and Signatures Chapter 9 In-Vitro Diagnostic Product Guidance Chapter 10 Design Review Guidance Chapter 11 Risk Management Guidance Chapter 12 Quality System Inspection Technique Chapter 13 U.S. Compliance Programs for Medical Devices Section 2 Technical Knowledge Chapter 14 Sterilization Chapter 15 Biocompatibility Chapter 16 Controlled Environments and Utility Systems Chapter 17 Software Chapter 18 Laboratory Testing Section 3 International Standards and Guidance Chapter 19 International Quality System Guidance Chapter 20 The EU Medical Device Directive Chapter 21 International Auditing Guidelines References Bibliography Index
Library of Congress Subject Headings for this publication: Medical instruments and apparatus Quality control Handbooks, manuals, etc