Table of contents for The biomedical quality auditor handbook / Bruce Haggar, editor.


Bibliographic record and links to related information available from the Library of Congress catalog. Note: Contents data are machine generated based on pre-publication information provided by the publisher. Contents may have variations from the printed book or be incomplete or contain other coding.


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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