دانلود کتاب Clinical Evaluations for Medical Devices

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Cover
Title Page
Copyright
ABOUT THE AUTHOR
TABLE OF CONTENTS
List of Abbreviations
Introduction
Preface
Chapter 1 What Is a Clinical Evaluation Report (CER)?
Chapter 2 Understanding MEDDEV 2.7/1 (Revision 04) in Greater Detail: MEDDEV 2.7/1 (Rev 04) – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC
Chapter 3 Essential Requirements (ERs) of Medical Devices (Under the MDD 93/42 EEC)
Chapter 4 General Safety and Performance Requirements (GSPRs) of Medical Devices (Under the MDR 2017/745)
Chapter 5 Claiming Equivalence Between Medical Devices
Chapter 6 MDCG 2020-5: Clinical Evaluation – Equivalence: A Guide for Manufacturers and Notified Bodies
Chapter 7 Differences in Technical, Biological, and Chemical Characteristics
Chapter 8 Demonstration of Equivalence
Chapter 9 Use of Data From Similar Devices
Chapter 10 How to Conduct a Literature Review?
Chapter 11 When to Update Your CER?
Chapter 12 What Is a Clinical Evaluation Plan?
Chapter 13 Post-market Clinical Follow-Up (PMCF)
Appendices
Bibliography
Index
Back Cover