The Medical Device Validation Handbook, Second Edition: Hardcover 2018

ISBN-13: 9781947493094

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This book is a must-have for those involved in the verification and validation of medical devices for the US market. It not only updates information from the original, it includes seven new chapters. The handbook covers device validation and revalidation throughout the product lifecycle, from design through postmarket. It clearly details how and why various processes and equipment must be validated and how the methodology had progressed. The new chapters discuss the need for test method validation, device test method validation, design of experiments, additive (3D printing) manufacturing, cybersecurity and data integrity, validation of the laser welding process and the set-up of cleanrooms, both initially and following a worst-case event. Updated chapters include, among others, the history of device validation and validation of design, sterilization, packaging, cleaning, software and equipme

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