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The Medical Device Validation Handbook, Second Edition

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The Medical Device Validation Handbook, Second Edition

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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 equipment.

Who Should Buy This Handbook?

The handbook is essential for medical device companies who depend on their employees’ understanding of validation and verification processes. This includes regulatory, design and development, management, quality, packaging engineers, sterilization, software and manufacturing engineers. It also is relevant to American Society for Quality (ASQ) professionals and the information provided can be applied as easily to small companies as to larger firms. 
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