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The Medical Device Validation Handbook, Third Edition (e-book)

Member: $160.00 Nonmember: $225.00
The Medical Device Validation Handbook, Third Edition (e-book)

Table of Contents

Sample Chapter

Editor

Robert Falcone, PhD, FRAPS, FTOPRA

Product Description

Maintaining a healthy quality system and complying with the Food and Drug Administration’s expectations has never been more important for manufacturers making medical devices bound for the US market. Stay current with The Medical Device Validation Handbook, Third Edition, an e-book from RAPS that will help you stay one step ahead of regulators.
 
With 18 chapters chock-full of must-know information, tips, and expert insight, the handbook is a necessary addition to the bookshelf of any regulatory or quality professional involved in the verification and validation of devices bound for the US market. The handbook covers in detail validation and revalidation activities that span the lifecycle of a device, from cradle to grave. It further details how and why various processes and equipment must be validated, and how the methodology has progressed.

Who should buy this book?

Countless FDA warning letters and inspectional observation forms are issued by the agency each year to medical device companies, with many citing a failure to ensure that processes were validated or revalidated. But with The Medical Device Validation Handbook, Third Edition, your firm doesn’t have to be one of them. Regulatory and quality assurance professionals at Levels 1 and 2 of the RAPS Regulatory Competency Framework can rest assured knowing they have the most relevant and comprehensive guidance for walking them through verification and validation activities to ensure they’re in compliance every step of the way.


Meet the Authors

Meet Jay Crowley, who coauthored the UDI chapter for The Medical Device Validation Handbook, Third Edition, and coined the term “Unique Device Identification” while an official at the Food and Drug Administration. In this interview he talks UDI verification and validation activities, where medical device firms fall down when implementing UDI, FDA compliance and enforcement issues around UDI, and more.

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