Medical Device Software Verification, V

David A Vogel

ISBN 10: 1596934220 / ISBN 13: 9781596934221

Published by Artech House Publishers Dez 2010, 2010

About this Item

Neuware - Here's 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 a much broader, higher-level picture than other books in this field, this book helps professionals think critically about software validation -- to build confidence in their software's safety and effectiveness. The book presents validation activities for each phase of the product 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, and in compliance with regulations.

Seller Inventory # 9781596934221

Bibliographic Details

• Title: Medical Device Software Verification, V
• Publisher: Artech House Publishers Dez 2010
• Publication Date: 2010
• Language: English
• ISBN 10: 1596934220
• ISBN 13: 9781596934221
• Binding: Buch
• Condition: Neu
• Dimensions: 259W x 183H x 25D millimeters 259 millimeters width by 183 millimeters height by 25 millimeters depth
• Weight: 975 grams

About this title

Synopsis

Note: This is a print on demand, reproduction of the original title and does not include any DVD

Here s 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 software s 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, and in compliance with regulations. 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).

About the Author

David A. Vogel is founder and president of Intertech Engineering Associates, Inc. in Westwood, Massachusetts. The company specializes in the management of hardware and embedded software development and verification/validation projects for medical devices. He has also served as principal bioengineer at Becton Dickinson Medical Systems, and as software engineer for Honeywell Information Systems. He has earned degrees in biomedical engineering and computer science from the University of Michigan and Massachusetts Institute of Technology.