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Biocompatibility and Performance of Medical Devices (Woodhead Publishing Series in Biomaterials) - Tapa dura

Libro 51 de 343: Woodhead Publishing Series in Biomaterials
 
9780857090706: Biocompatibility and Performance of Medical Devices (Woodhead Publishing Series in Biomaterials)

Sinopsis

Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices.Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies.With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics.

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Acerca del autor

Jean-Pierre (JP) Boutrand, DVM, MS is a Senior Vice President at Eurofins, Luxembourg.

Dr. Boutrand is an executive leader, veterinarian, and recognized authority in nonclinical evaluation, biological safety, and testing strategies for medical devices and combination products. With over 25 years of global leadership―including senior executive roles at NAMSA (Vice President of Global Laboratory Services), Labcorp, Charles River Laboratories and Eurofins―Dr. Boutrand has guided the safety, compliance, and commercialization pathways for hundreds of complex medical devices worldwide. A former registered expert on the biological safety of medical devices for regulatory agencies including ANSM, Dr. Boutrand specialized in integrated risk management, ISO 10993 compliance, toxicology assessment strategies, and pharmacology models. He is the editor and author of the textbook Biocompatibility and Performance of Medical Devices (Woodhead Publishing / Elsevier), currently in its 3rd edition, and has authored over 120 scientific publications and global conference presentations on biomaterial safety, histopathology, and regulatory evaluation frameworks.

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