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• W2076300851 abstract "Author: David Vogel, Publisher: Artech House, ISBN: 978-1-59693-422-1, Publication Date: 2011, Pages: 424, Price: $129Validating medical device software can be challenging, especially when the software is a component part of or is embedded within a more complex medical device. Not only is it necessary to develop and test the software, but it must be validated in accordance with regulatory expectations, often with reference to the broader medical device. Whether you're a large multinational medical device corporation or a small start-up, validating medical device software needs to be right the first time. David Vogel is a software developer and an exceptional writer. This book offers a systematic, step-by-step approach to the validating process. It provides the reader practical templates for achieving success and explains how to get from the starting point to “go live” in the most time-efficient and effective way.Audience: This book will provide useful information and recommendations to quality assurance engineers, regulatory compliance professionals, design engineers, manufacturing process owners, and software developers who are engaged in medical device quality system regulation. Vogel covers both the design and development phase as well as post-commercialization revalidation opportunities. FDA scientific reviewers, investigators, and compliance officers would also benefit from this very practical book, which deals with real-time solutions to rather multifarious inputs and outputs.Features: This book is written in a refreshingly distinctive manner to help readers better understand and implement critical verification and validation processes for medical device software. It offers a much a broader, higher-level picture than other books I've read. The book presents validation activities for each phase of the development lifecycle; shows why these activities are important and how they add value; explains how to undertake them; and tells what outputs need to be created to document the validation process. From software embedded within medical devices to software that performs as a medical device itself, this wideranging book explains how properly designed and implemented validation throughout the development lifecycle can help bring medical devices to the commercialization phase in an expeditious and compliant manner.Vogel reminds the reader repeatedly why validation is important and why each activity is important, and how this should add to the confidence in the software being developed and then validated. In devices of any complexity, analyzing the software in isolation from the rest of the device's subsystems can give a distorted view of the effectiveness of the software. This is true of validation, and Vogel addresses this pivotal issue in various chapters of the book. Chapter 18 is very informative as risk management, defect management, and configuration management are so interrelated. Those topics are effectively dissected by the author (who obviously has spent time in the trenches).Additionally, an entire part of the book is devoted to the validation of software that automates any part of a manufacturer's quality system and is regulated by 21 CFR 820.70(i). This book also comes with a DVD that provides a comprehensive menu of up-to-date U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) guidance documents with regulatory and quality systems' orientation in mind.The author uses practical applications and examples to facilitate complex academic points of interest. For instance, he talks about experience and how it has been the driving force behind design input requirements, how it dictates the amount of review, the quantity of tests written, and the number of times the tests are executed.Assessment: This book is on my “top shelf” and well within reach of my desk when a practical and informative reference is required. The DVD is exceptional and requires only one stop when investigating the regulations, improved ideas, and making timely regulatory decisions. This is a well-written, edited, and organized book that effectively deals with subjects that have long been associated with mysticism, lack of regulatory guidance, and contradictory information." @default.
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• W2076300851 title "<i>Medical Device Software: Verification, Validation and Compliance</i>" @default.
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