Title: Biocompatibility and Performance of Medical Devices (Woodhead Publishing Series in Biomaterials)
Publisher: Elsevier
Publication Date: 2019
Language: English
ISBN 10: 0081026439
ISBN 13: 9780081026434
Binding: Soft cover
Edition: 2nd Edition
Condition: New

About this title

Synopsis

Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies.

Presents diverse insights from experts in government, industry and academia
Delivers a comprehensive overview of testing and interpreting medical device performance
Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market

About the Author

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).

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