Medical Device Software Verification, Validation and Compliance

Medical Device Software Verification, Validation and Compliance PDF

Author: David A. Vogel

Publisher: Artech House

Published: 2011

Total Pages: 445

ISBN-13: 1596934239

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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."

Compliance Quantified

Compliance Quantified PDF

Author: Rudolf Avenhaus

Publisher: Cambridge University Press

Published: 1996-05-30

Total Pages: 272

ISBN-13: 0521553660

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A self-contained 1996 account of the game theory and statistics used in modelling compliance with international agreements.

Verification in an Age of Insecurity

Verification in an Age of Insecurity PDF

Author: Philip D. O'Neill (Jr.)

Publisher: Oxford University Press, USA

Published: 2010

Total Pages: 224

ISBN-13: 0195389263

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Verification in an Age of Insecurity takes the reader into some of the most urgent arms control issues facing the world community, including the nuclear activities of rogue states and threats from sophisticated non-state actors. In the book, national security expert Philip D. O'Neill, Jr. identifies and addresses issues from the resuscitated disarmament agenda, from the comprehensive test ban to fissile material and biological weapons. O'Neill examines the need for shifts in verification standards and policy suitable for our volatile era and beyond it. He surveys recent history to show how established verification procedures fail to produce the certainty necessary to meet today's threats. Verification in an Age of Insecurity goes beyond a discussion of rogue states like North Korea to offer suggestions on how best to bring compliance policy up to date with modern threats.

Coming to Terms with Security

Coming to Terms with Security PDF

Author: United Nations Institute for Disarmament Research

Publisher: United Nations Publications UNIDIR

Published: 2003

Total Pages: 354

ISBN-13:

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Good verification and compliance arrangements can significantly promote confidence building in areas considering decreasing arms or, military capabilities fearing that reductions may compromise rather than, enhance their security. This publication provides basic guidelines on verification and compliance in the field of arms control and disarmament. It is a convenient handbook for officials involved in arms control and disarmament activities, students, researchers, and journalists. The book is a collaborative effort between United Nations Institute for Disarmament Research (UNIDIR) and the Verification Research Training and Information Centre (VERTIC) in London. This bilingual publication contains information both in Arabic and English.