Medical Device Software Verification, Validation, and Compliance

Medical Device Software Verification, Validation, and Compliance

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HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and 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 comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations.qOne can only imagine how desperate the company must have been to offer some help to the users as quickly as possible. ... The user manual was difficult to understand, provided no information to explain the meaning of error codes, nor did itanbsp;...

Title:Medical Device Software Verification, Validation, and Compliance
Author:David A. Vogel
Publisher:Artech House - 2010


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