Biocompatibility and Performance of Medical Devices

<p>Part One Introduction to biocompatibility in medical devices 000</p> <p>1 Strategies to accelerate medical market access and manage risks of biocompatibility<br>R. Eloy and S.J. Goldenberg</p> <p>2 Making use of a biological safety evaluation plan <br>D. Parente</p> <p>3 Biomechanical and biochemical compatibility in innovative biomaterials <br>J. Huang, X. Li, and Z.X. Guo</p> <p>Part Two Evaluation and characterization of biocompatibility in medical devices</p> <p>4 A practical approach to analytical chemistry of medical devices<br>D.E. Albert</p> <p>5 Tolerable intake values for leachables: Practical use of ISO 10993-17 standard <br>R.P. Brown</p> <p>6 In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices <br>W.H. De Jong, J.W. Carraway, and R.E. Geertsma</p> <p>7 Practical approach to blood compatibility assessments: General considerations and standards <br>M.F. Wolf and J.M. Anderson</p> <p>8 Quality strategies that fasten devices access to global markets <br>J.A. Torfin and S. Gompertz</p> <p>9 Accelerating medical device biocompatibility evaluation: An industry perspective <br>K.P. Coleman, W.V. Christian, and W. Zhang</p> <p>10 Overcoming negative test results during manufacture <br>D. Parente</p> <p>11 Methods for the characterization and evaluation of drug-device combination products<br>A.L. Lewis</p> <p>Part Three Testing and interpreting the performance of medical devices </p> <p>12 Efficient evaluations of bone implants performances <br>J.-P. Boutrand</p> <p>13 Methods and interpretation of performance studies for dental implants<br>M. Dard</p> <p>14 Optimizing the design of preclinical safety and performance studies—Examples in soft tissues and cardio-vascular implants <br>E. Drevon-Gaillot, T. Blair, and G. Clermont</p> <p>15 Mechanical testing for soft and hard tissue implants<br>C. Kaddick</p> <p>Part Four International regulation of medical devices</p> <p>16 Biological evaluation and regulation of medical devices in the European Union<br>T. Keene</p> <p>17 Biological evaluation and regulation of medical devices in Japan<br>K. Kojima and K. Sakaguchi</p> <p>18 Medical device regulations in China <br>C. Shan and M. Liu</p> <p>Part Five Histopathology principles for biocompatibility and performance studies</p> <p>19 Current considerations in medical device pathology<br>A. Alves, L. Wancket, A. Metz</p>