Biocompatibility and Performance of Medical Devices

Jean-Pierre Boutrand is General Manager and Scientific Director for the European division of NAMSA (the world leading medical device evaluation company). Dr Boutrand has been involved in more than 100 public presentations and publications on topics related to medical device evaluation and is registered as an expert on the biological safety of medical devices for ANSM (the French agency for the safety of health products).

• Part One Introduction to biocompatibility in medical devices 0001 Strategies to accelerate medical market access and manage risks of biocompatibilityR. Eloy and S.J. Goldenberg2 Making use of a biological safety evaluation plan D. Parente3 Biomechanical and biochemical compatibility in innovative biomaterials J. Huang, X. Li, and Z.X. GuoPart Two Evaluation and characterization of biocompatibility in medical devices4 A practical approach to analytical chemistry of medical devicesD.E. Albert5 Tolerable intake values for leachables: Practical use of ISO 10993-17 standard R.P. Brown6 In vivo and in vitro testing for the biological safety evaluation of biomaterials and medical devices W.H. De Jong, J.W. Carraway, and R.E. Geertsma7 Practical approach to blood compatibility assessments: General considerations and standards M.F. Wolf and J.M. Anderson8 Quality strategies that fasten devices access to global markets J.A. Torfin and S. Gompertz9 Accelerating medical device biocompatibility evaluation: An industry perspective K.P. Coleman, W.V. Christian, and W. Zhang10 Overcoming negative test results during manufacture D. Parente11 Methods for the characterization and evaluation of drug-device combination productsA.L. LewisPart Three Testing and interpreting the performance of medical devices 12 Efficient evaluations of bone implants performances J.-P. Boutrand13 Methods and interpretation of performance studies for dental implantsM. Dard14 Optimizing the design of preclinical safety and performance studies—Examples in soft tissues and cardio-vascular implants E. Drevon-Gaillot, T. Blair, and G. Clermont15 Mechanical testing for soft and hard tissue implantsC. KaddickPart Four International regulation of medical devices16 Biological evaluation and regulation of medical devices in the European UnionT. Keene17 Biological evaluation and regulation of medical devices in JapanK. Kojima and K. Sakaguchi18 Medical device regulations in China C. Shan and M. LiuPart Five Histopathology principles for biocompatibility and performance studies19 Current considerations in medical device pathologyA. Alves, L. Wancket, A. Metz