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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."
A self-contained 1996 account of the game theory and statistics used in modelling compliance with international agreements.
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.
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.
Since the last edition of this book 61/2 years ago, worksite enforcement has surged at both federal and state levels. By 2024, 26 states have enacted employer sanctions laws, with nine mandating E-Verify for all eligible employers and 12 requiring it for contractors engaged in state or local government projects. Other states have implemented immigration laws pertaining to employers, some without E-Verify requirements. Companies now face severe penalties, such as license revocation and contract denial, if found hiring unauthorized workers. The enforcement of employer sanctions and anti-discrimination regulations under the Immigration Reform and Control Act (IRCA) falls under the jurisdiction of two agencies: U.S. Immigration and Customs Enforcement (ICE) and the Immigrant and Employee Rights Section of the Civil Rights Division at the Department of Justice. Compliance with these regulations is mandatory for employers. However, navigating these laws has become increasingly intricate for today's employers, with further complexity anticipated. The I-9 and E-Verify Handbook aims to streamline this convoluted process, aiding human resource professionals, immigration advisors, and others in guiding employers through these challenging immigration regulations. The authors, Bruce E. Buchanan and Greg Siskind, discuss the array of statutes and regulations in an easy-to-understand, question-and-answer format with straightforward illustrations, flowcharts, checklists, and sample documents designed to help implement and improve an employer's immigration compliance program.