The Medical Device Validation Handbook, Third Edition (e-book)
Table of Contents
Chapter 1: Regulatory Basics of Process and Design Validation
Chapter 2: Risk-Based Verification and Validation
Chapter 3: Gap Assessments for Medical Devices
Chapter 4: Test Method Validation and How it Is Used for Medical Devices and Packaging
Chapter 5: Design of Experiments
Chapter 6: Sterilization Validation Principles
Chapter 7: Six Sigma Concepts in Validation Studies for Medical Device Packaging
Chapter 8: Medical Packaging Validation
Chapter 9: Cleaning Validations of Medical Products
Chapter 10: Software Validation for Life Sciences
Chapter 11: FDA Unique Device Identification Verification and Validation
Chapter 12: Equipment Validation
Chapter 13: Sample Sizes for Verification and Validation
Chapter 14: Verification and Validation in Medical Device Computational Modeling and Simulation
Chapter 15: Additive (3D Printing) Manufacturing
Chapter 16: Cybersecurity and Data Integrity
Chapter 17: Validating the Medical Device Laser-Welding Process
Chapter 18: Start-up of Cleanrooms, Initially and After a Worst-Case Event
Robert Falcone, PhD, FRAPS, FTOPRA, editor
About the Book
Available formats: e-book only
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.
Each chapter in this latest edition of The Medical Device Validation Handbook is designed to cover the essential elements for validation and verification and is written by 27 highly regarded and experienced authors who know their way around industry. Several chapters from the second edition have been revised to reflect new information, or clarify or augment previous material. The book is designed to be the most comprehensive and practical resource for quality, regulatory, and manufacturing personnel.
Relevant sources of information including US regulations, guidance documents, and international standards were tapped by our suite of expert authors to give even more pointers and advice on verification and validation efforts, including a chapter on conducting gap assessments and an expanded software validation chapter that clearly and concisely offers cutting-edge knowledge on computer software assurance. The handbook further gives the latest on medical device cybersecurity and data integrity, as well as hot topics like Unique Device Identification (UDI), 3D printing, sterilization, cleanrooms, and more.
Who will benefit from 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.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2023. E-book. 284 pages. ISBN (digital): 978-1-947493-89-6.
