Safety Evaluation in the Development of Medical Devices and Combination Products

Shayne C. Gad, Marian G. McCord

• Publisher: CRC Press
• Year: 2008
• eBook ISBN:
  9781040168813
• Topic: Medicine
• Subtopic: Medical Technology & Supplies

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-l

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Dedication
• Preface To The Third Edition
• Table of Contents
• 1 Introduction
• 2 Regulatory Aspects And Strategy In Medical Device And Bio Materials Safety Evaluation
• 3 Road Map To Test Selections
• 4 Materials In Medical Device Design
• 5 What To Test: Sampling And Sample Preparation
• 6 Cytotoxicity Testing
• 7 Hemocompatibility
• 8 Local Tissue Tolerance
• 9 Immunotoxicology
• 10 Implantation Biology And Studies
• 11 Acute Systemic Toxicity Testing Device Safety Evaluation
• 12 Genotoxicity
• 13 Subchronic And Chronic Toxicity And Reproductive And Developmental Toxicity
• 14 Carcinogenicity
• 15 Degradation Products And Impurities
• 16 Combination Products
• 17 Clinical Studies For Medical Devices
• 18 Special Studies
• 19 Toxicokinetics In Biomaterial And Device Safety Evaluation
• 20 Case Histories And Problem Resolution
• Appendix A
• Appendix B
• Appendix C
• Appendix D
• Index