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Books > Law > Laws of other jurisdictions & general law > Constitutional & administrative law > General

The Appearance of Corruption - Testing the Supreme Court's Assumptions about Campaign Finance Reform (Hardcover): Daron R.... The Appearance of Corruption - Testing the Supreme Court's Assumptions about Campaign Finance Reform (Hardcover)
Daron R. Shaw, Brian E. Roberts, Mijeong Baek
R1,177 Discovery Miles 11 770 Ships in 10 - 15 working days

A critical analysis of the connections that the United States Supreme Court has made between campaign finance regulations and voters' behavior. The sanctity of political speech is a key element of the United States Constitution and a cornerstone of the American republic. When the Supreme Court linked political speech to campaign finance in its landmark Buckley v. Valeo (1976) decision, the modern era of campaign finance regulation was born. The decision stated that in order to pass constitutional muster, any laws limiting money in politics must be narrowly tailored and serve a compelling state interest. The lone state interest the Court was willing to entertain was the mitigation of corruption. In order to reach this conclusion, the Court advanced a sophisticated behavioral model that made assumptions about how laws affect voters' opinions and behavior. These assumptions have received surprisingly little attention until now. In The Appearance of Corruption, Daron Shaw, Brian Roberts, and Mijeong Baek analyze the connections that the Court made between campaign finance regulations and voters' behavior. The court argued that an increase in perceived corruption would lower engagement and turnout. Drawing from original survey data and experiments, they confront the question of what happens when the Supreme Court is wrong-and when the foundation of over 40 years of jurisprudence is simply not true. Even with the heightened awareness of campaign finance issues that emerged in the wake of the 2010 Citizens United decision, there is little empirical support for the Court's reasoning that turnout would decline. A rigorous statistical analysis, this is the first work to simultaneously name and test each and every one of the Court's assumptions in the pre- and post-Citizen's United eras. It will also fundamentally reshape how we think about campaign finance regulation's effects on voter behavior.

Tudor Government (Hardcover): Loades Tudor Government (Hardcover)
Loades
R3,352 Discovery Miles 33 520 Ships in 10 - 15 working days

This book examines the structures of power and jurisdiction that operated in Tudor England. It explains what the institutions of central government were designed to do, and how they related to each other. It discusses how order and obedience were supposed to be preserved in the countryside, and it shows how the offices designed for that purpose worked in practice. In doing so, Professor Loades highlights the complex links between the formal and informal systems of peace-keeping that functioned throughout the country and examines the critical relationship between Church and State, providing readers with an important context for the social and political developments of the age.


The book shows the extent to which changes to the monarch's status affected his real power both within the Church and within his kingdom as a whole. It explores the tensions surrounding his position: the king administered the law, but he did not make it; he could claim revenue, but it had to be granted to him; he was head of the government and the Lords Annointed, but limited by innumerable customs and obligations. In unravelling the mysteries of this ancient and cumbersome system of government," Tudor Government" offers a valuable introduction to this complex yet pivotal aspect of early modern British history.

Constitutional Rights after Globalization (Hardcover, New): Gavin Anderson Constitutional Rights after Globalization (Hardcover, New)
Gavin Anderson
R2,853 Discovery Miles 28 530 Ships in 10 - 15 working days

Constitutional Rights after Globalization juxtaposes the globalization of the economy and the worldwide spread of constitutional charters of rights. The shift of political authority to powerful economic actors entailed by neo-liberal globalization challenges the traditional state-centred focus of constitutional law. Contemporary debate has responded to this challenge in normative terms, whether by reinterpreting rights or redirecting their ends, e.g. to reach private actors. However, globalization undermines the liberal legalist epistemology on which these approaches rest, by positing the existence of multiple sites of legal production, (e.g. multinational corporations) beyond the state. This dynamic, between globalization and legal pluralism on one side, and rights constitutionalism on the other, provides the context for addressing the question of rights constitutionalism's counterhegemonic potential. This shows first that the interpretive and instrumental assumptions underlying constitutional adjudication are empirically suspect: constitutional law tends more to disorder than coherence, and frequently is an ineffective tool for social change. Instead, legal pluralism contends that constitutionalism's importance lies in symbolic terms as a legitimating discourse. The competing liberal and 'new' politics of definition (the latter highlighting how neoliberal values and institutions constrain political action) are contrasted to show how each advances different agenda. A comparative survey of constitutionalism's engagement with private power shows that conceiving of constitutions in the predominant liberal, legalist mode has broadly favoured hegemonic interests. It is concluded that counterhegemonic forms of constitutional discourse cannot be effected within, but only by unthinking, the dominant liberal legalist paradigm, in a manner that takes seriously all exercises of political power.

The Historical Foundations of EU Competition Law (Hardcover, New): Kiran Klaus Patel, Heike Schweitzer The Historical Foundations of EU Competition Law (Hardcover, New)
Kiran Klaus Patel, Heike Schweitzer
R3,240 Discovery Miles 32 400 Ships in 10 - 15 working days

Shedding new light on the foundations of European competition law, this volume is a legal and historical study of the emerging law and its evolution through the 1980s. It retraces the development and critical junctures of competition law not only at the level of the European Economic Community but also at the level of major Member States of the EEC. Intensely researched and rich with insights, the chapters in this volume reflect a close collaboration among an expert group of lawyers and historians and capitalize on previously unavailable source materials. The book examines several key themes including: the influence of national and international competition law on the development of EEC competition law; the drafting of the regulations that lead to the development of modern EU competition law; the role of the European Court of Justice in establishing the protection of competition as a central pillar of the Common Market; the internal dynamics, ideologies and tensions within the Competition Directorate General (DG IV) of the European Commission; and the role of industrial policy in European integration. Combining legal analysis with a meticulous excavation of historical evidence to reveal the forces driving key actors and the interactions among them, this volume rediscovers a past largely forgotten but essential to understanding the genesis of competition law in Europe, its role in Europe's construction, its hybrid institutional traits, and its often unique substance.

Church-State Constitutional Issues - Making Sense of the Establishment Clause (Hardcover, New): Doanld Drakeman Church-State Constitutional Issues - Making Sense of the Establishment Clause (Hardcover, New)
Doanld Drakeman
R2,214 R2,045 Discovery Miles 20 450 Save R169 (8%) Ships in 10 - 15 working days

Church-State Constitutional Issues explores the often-debated and always topical issue of the relationship between church and state as outlined in the First Amendment. Donald L. Drakeman takes an interdisciplinary approach to examine the meaning of the establishment clause, demonstrating how the studies of law, religion, history, and political science provide insight into this relationship, which, since the nation's inception, has been difficult to define. The study first chronicles the Supreme Court's decision regarding the interpretation of the establishment clause from the early 19th century to the present. This legal history is subsequently viewed from a cultural perspective as Drakeman traces both the background of the First Amendment and how the relationship of church and state has developed on its journey through the court system. The volume moves towards further understanding of this complex issue as it concludes with a new interpretation of the establishment clause derived from previous information as well as further legal and political interpretive material.

Digital Solutions for Contemporary Democracy and Government (Hardcover): Kelvin Joseph Bwalya, Stephen Mutula Digital Solutions for Contemporary Democracy and Government (Hardcover)
Kelvin Joseph Bwalya, Stephen Mutula
R5,010 Discovery Miles 50 100 Ships in 18 - 22 working days

The dot-com revolution has brought many advances before unimagined. Of them all, it may be said that none have surpassed e-government in attracting a significant number of researchers and practitioners from around the world. However, the question remains whether everyone is ready to join the e-government movement, or if some are just blindly following the latest trend. Digital Solutions for Contemporary Democracy and Government touches on several key issues and challenges surrounding the recent e-government boom and offers practical solutions from those who have been a part of implementing e-government programs internationally. Due to its breadth of discussion on a variety of topics relating to the intersection of technology with politics, democracy, and government, this authoritative book is a valuable reference source for professionals, researchers, and students in the field of e-government, information management, or knowledge management.

Our Weakened Constitution - An Historical and Analytical Study of the Constitution of the United States (Hardcover): Samuel... Our Weakened Constitution - An Historical and Analytical Study of the Constitution of the United States (Hardcover)
Samuel Bell Thomas, Edward Williams; Introduction by John R. Vile
R1,452 Discovery Miles 14 520 Ships in 10 - 15 working days
Abortion and the Law - From International Comparison to Legal Policy (Hardcover, Edition.): Albin Eser, Hans-Georg Koch Abortion and the Law - From International Comparison to Legal Policy (Hardcover, Edition.)
Albin Eser, Hans-Georg Koch
R3,827 Discovery Miles 38 270 Ships in 18 - 22 working days

Abortion is a quasi-eternal problem of humanity. For decades it has been - and continues to be - a highly debated political and legal issue in the Western world on both sides of the Atlantic. The contending political camps are often defined as 'pro-life' or 'pro-choice'. From a more legal perspective, the opposing positions may be described by the terms 'indication model' - where terminations are permitted in certain circumstances - and 'time limitation model' - where termination within a certain period of pregnancy is permitted on demand. Based upon a worldwide survey on abortion law and practice in a total of 64 countries carried out by the Max-Planck Institute for Foreign and International Criminal Law in Freiburg (Germany), the authors developed a 'third way'. This 'third way', which may be described as a 'discourse model', reflects the conviction that the decision to terminate must, in the final analysis, be taken by the pregnant woman herself subject to her own responsibility and that the legal system must treat her decision with respect. Along with a summary of social conditions and historical developments and a detailed comparison of legal regulations, supplemented by statistics on the termination of pregnancy, the authors arrive at their concluding reflections. Important findings, insights and trends are summarized and starting points and guidelines for reforms are pointed out. The book ends with a proposed regulation intended to provide those interested in an optimal regulation of the issue with food for thought. Prof. Dr. Dr. h.c. mult., M.C.J. (New York) Albin Eser is presently a Judge at the International Criminal Tribunal for the former Yugoslavia and Director em. of the Max-Planck-Institute for Foreign and International Criminal Law, Freiburg, Germany. Dr. jur. Hans-Georg Koch is senior researcher, Head of the medical law department of the Max-Planck-Institute for Foreign and International Criminal Law, Freiburg, Germany.

True Copie of the Court Booke of the Governor and Society of the Massachusetts Bay in New England [manuscript] (Hardcover):... True Copie of the Court Booke of the Governor and Society of the Massachusetts Bay in New England [manuscript] (Hardcover)
Samuel L M (Samuel Latham M Barlow, John 1588?-1665 Endecott; Anne 1591-1643 Hutchinson
R887 Discovery Miles 8 870 Ships in 10 - 15 working days
The Bench and Bar of Georgia - Memoirs and Sketches, With an Appendix, Containing a Court Roll From 1790 to 1857, Etc.... The Bench and Bar of Georgia - Memoirs and Sketches, With an Appendix, Containing a Court Roll From 1790 to 1857, Etc. (Hardcover)
Stephen Frank 1810?-1867 Miller
R922 Discovery Miles 9 220 Ships in 18 - 22 working days
Fathers to Daughters - The Legal Foundations of Female Emancipation (Hardcover): Peggy Rabkin Fathers to Daughters - The Legal Foundations of Female Emancipation (Hardcover)
Peggy Rabkin
R2,512 R2,213 Discovery Miles 22 130 Save R299 (12%) Ships in 10 - 15 working days
A Digest of the Law of Easements (Hardcover): L C (Lewis Charles) Innes A Digest of the Law of Easements (Hardcover)
L C (Lewis Charles) Innes
R807 Discovery Miles 8 070 Ships in 18 - 22 working days
Shi'i Jurisprudence and Constitution - Revolution in Iran (Hardcover, New): A. Boozari Shi'i Jurisprudence and Constitution - Revolution in Iran (Hardcover, New)
A. Boozari
R2,655 Discovery Miles 26 550 Ships in 18 - 22 working days

Substantially about the relation between the concept of constitutionalism and Islamic Law in general and how such relation is specifically reflected in the Shi'ite jurisprudence, this volumeexplores the juristic origins of constitutionalism, especially in the context of 1905 Constitutional Revolution in Iran. Boozari has introduced the most important fatwas issued by the religious leaders in support of constitutionalism during the 1905 revolution, unfolded their underpinning theories, and analyzed the juristic technicalities of the terms.

Hints on Advocacy, Intended for Practitioners in Civil and Criminal Courts (Hardcover): Richard Harris Hints on Advocacy, Intended for Practitioners in Civil and Criminal Courts (Hardcover)
Richard Harris
R831 Discovery Miles 8 310 Ships in 18 - 22 working days
Constitutional Remedies - A Reference Guide to the United States Constitution (Hardcover): Michael Wells, Thomas A. Eaton Constitutional Remedies - A Reference Guide to the United States Constitution (Hardcover)
Michael Wells, Thomas A. Eaton
R2,543 Discovery Miles 25 430 Ships in 10 - 15 working days

Understanding the impact of constitutional rights in the real world depends on understanding the law of constitutional remedies for their violation. Integrating the history, doctrine, and policy of constitutional remedy, Wells and Eaton explain how people go about trying to obtain redress for violations of their constitutional rights. Diverse issues arise when persons seek to bring a lawsuit against governments, officials, or private individuals for violation of their constitutional rights. Among them are whether the injury ought to be accorded constitutional status at all, or instead should be treated as a routine wrong, no different in principle from a traffic accident. If the case warrants constitutional status, the next issue is whether or not suit may be brought against the officer who committed the wrong or his government employer, and so on. On each of these and other issues the authors guide the reader through the complex body of doctrine, the lively case law debates, and the scholarly literature over the appropriate mix of policies and the means by which to achieve them.

The European Crisis and the Transformation of Transnational Governance - Authoritarian Managerialism versus Democratic... The European Crisis and the Transformation of Transnational Governance - Authoritarian Managerialism versus Democratic Governance (Hardcover)
Christian Joerges, Carola Glinski
R4,655 Discovery Miles 46 550 Ships in 10 - 15 working days

The debate on law, governance and constitutionalism beyond the state is confronted with new challenges. In the EU, confidence in democratic transnational governance has been shaken by the authoritarian and unsocial practices of crisis management. The ambition of this book, which builds upon many years of close co-operation between its contributors, is to promote a viable interdisciplinary alternative to these developments. "Conflicts-law constitutionalism" is a concept of transnational governance which derives democratic legitimacy from the supranational control of the external impact of national decision-making, on the one hand, and the co-operative responses to problem interdependencies on the other. The first section of the book contrasts Europe's new modes of economic governance and crisis management with the conditionality of international investments, and reflects upon the communalities and differences between emergency Europe and global exceptionalism. Subsequent sections substantiate the problematique of executive and technocratic rule, explore conflict constellations of prime importance in the fields of environmental and labour law, and discuss the impact and limits of liberalisation strategies. Throughout the book, European and transnational developments are compared and evaluated.

Reconstituting the Constitution (Hardcover, 2011 ed.): Caroline Morris, Jonathan Boston, Petra Butler Reconstituting the Constitution (Hardcover, 2011 ed.)
Caroline Morris, Jonathan Boston, Petra Butler
R4,102 Discovery Miles 41 020 Ships in 18 - 22 working days

All nation states, whether ancient or newly created, must examine their constitutional fundamentals to keep their constitutions relevant and dynamic. Constitutional change has greater legitimacy when the questions are debated before the people and accepted by them. Who are the peoples in this state? What role should they have in relation to the government? What rights should they have? Who should be Head of State? What is our constitutional relationship with other nation states? What is the influence of international law on our domestic system? What process should constitutional change follow? In this volume, scholars, practitioners, politicians, public officials, and young people explore these questions and others in relation to the New Zealand constitution and provide some thought-provoking answers. This book is recommended for anyone seeking insight into how a former British colony with bicultural foundations is making the transition to a multicultural society in an increasingly complex and globalised world.

Tradition and Change in Administrative Law - An Anglo-German Comparison (Hardcover, 2007 ed.): Marina Kunnecke Tradition and Change in Administrative Law - An Anglo-German Comparison (Hardcover, 2007 ed.)
Marina Kunnecke
R4,157 Discovery Miles 41 570 Ships in 18 - 22 working days

Administrative legal systems are based on national constitutional legal traditions and cultural values. This book offers a historical and comparative analysis of English and German Administrative law. There is a growing need for comparative material and analysis in Administrative law - this book provides a valuable contribution to this field.

Uninhibited, Robust, and Wide-Open - A Free Press for a New Century (Hardcover): Lee C. Bollinger Uninhibited, Robust, and Wide-Open - A Free Press for a New Century (Hardcover)
Lee C. Bollinger
R590 Discovery Miles 5 900 Ships in 10 - 15 working days

Lee Bollinger is one of our foremost experts on the First Amendment--both an erudite scholar and elegant advocate. In this sweeping account, he explores the troubled history of a free press in America and looks toward the challenges ahead.
The first amendment guaranteed freedom of the press in seemingly clear terms. However, over the course of American history, Bollinger notes, the idea of press freedom has evolved, in response to social, political, technological, and legal changes. It was not until the twentieth century that freedom of the press came to be understood as guaranteeing an "uninhibited, robust and wide-open" public discourse. But even during the twentieth century, government continually tried to erect barriers: the sedition laws of World War One, the use of libel law, the Pentagon Papers case, and efforts to limit press access to information.
Bollinger utilizes this history to explore the meaning of freedom of the press in our globalized, internet-dominated era. As he shows, we have now entered uncharted territory. What does press freedom mean when our news outlets can instantaneously disseminate information throughout the world? When foreign media have immediate access to the American market? Bollinger stresses that even though the law will surely evolve in the coming years, we must maintain our commitment to a press that is "uninhibited, robust, and wide-open," not only in America but everywhere. Given the new ability of foreign media to reach the United States via the Internet and vice versa, it is in America's national interest for press freedoms to expand overseas. While protecting the freedom of the press at home remains a crucial task, the next challenge is to help create a global public forum suitable for an increasingly interconnected world. Part of Oxford's landmark Inalienable Rights series, this book will set the agenda for how we think about the press in the twenty-first century.

The Disability Pendulum - The First Decade of the Americans With Disabilities Act (Hardcover, Parental Adviso): Ruth Colker The Disability Pendulum - The First Decade of the Americans With Disabilities Act (Hardcover, Parental Adviso)
Ruth Colker
R2,860 Discovery Miles 28 600 Ships in 18 - 22 working days

View the Table of Contents.
Read the Introduction.

"Colker's book provides a comprehensive review of the ADA's history and a thorough analysis of how effective it has been in vindicating the rights of the disabled. She does not paint a pretty picture, but it is an accurate, empirically based assessment."
--"Trial"

"[A] comprehensive, factually-supported, and carefully reasoned book in a manner worthy of academic interest. At the same time, [Colker] writes in a plain style free of academic jargon and returns consistently to the human-interest arena of practical ramifications."
--"New York Law Journal"

"This book is must reading for teachers, school administrators, parents, vocational rehabilitation counselors, disability rights lawyers, and Deaf Community leaders who hope to help take the citizen ship interests of deaf and hard-of-hearing people to the next level. The book helps these constituencies make the essential connections between raising and educating deaf children and the rights and opportunities those children hope to enjoy."
--Journal of Deaf Studies and Deaf Education

"The Disability Pendulum chronicles societal views and court reactions to the evolving ADA. Ruth Colker shows that public acceptance and inclusion of persons with disabilities into society is as much driven by attitudes about disability as by law and policy themselves. Colker offers an enriched and fresh analysis of the forces affecting the civil rights movement of persons with disabilities in American society."
--Peter Blank, Charles M. and Marion Kierscht Professor of Law and Director, Law, Health Policy & Disability Center, University of Iowa College of Law

"Ruth Colker's bookis an absolute must-read for anyone interested in disability rights. Colker has long been one of the most astute observers of the development of disability rights in the courts. This book lays out the compelling story of what the ADA was intended to do and what the courts have done to the ADA. The book is both inspiring and sobering."
--Chai Feldblum, Georgetown University Law Center

a[Colker] does not paint a pretty picture, but is an accurate, empirically based assessmenta
-- Adele Rapport, The Associate Regional Attorney for the U.S. Equal Employment Opportunity Commissionas Indianapolis District Office

"The Disability Pendulum helps us to appreciate that how we address these issues will shape the lives of the next generation of children with disabilities."
--"The Law and Politics Book Review"

Signed into law in July 1990, the Americans with Disabilities Act (ADA) became effective two years later, and court decisions about the law began to multiply in the middle of the decade. In The Disability Pendulum, Ruth Colker presents the first legislative history of the enactment of the ADA in Congress and analyzes the first decade of judicial decisions under the act. She assesses the success and failure of the first ten years of litigation under the ADA, focusing on its three major titles: employment, public entities, and public accommodations.

The Disability Pendulum argues that despite an initial atmosphere of bipartisan support with the expectation that the ADA would make a significant difference in the lives of individuals with disabilities, judicial decisions have not been consistent with Congressa intentions. The courts have operated like a pendulum, at timesswinging to a pro-disabled plaintiff and then back again to a pro-defendant stance. Colker, whose work on the ADA has been cited by the Supreme Court, offers insightful and practical suggestions on where to amend the act to make it more effective in defending disability rights, and also explains judicial hostility toward enforcing the act.

Dignity and Liberty - Constitutional Visions in Germany and the United States (Hardcover): Edward J. Eberle Dignity and Liberty - Constitutional Visions in Germany and the United States (Hardcover)
Edward J. Eberle
R2,812 R2,546 Discovery Miles 25 460 Save R266 (9%) Ships in 10 - 15 working days

Striking a balance between the aspirations of individual freedom and the demands of organized society is a central quest of constitutional law. Germany and America provide different paths toward accomplishment of this equilibrium, revealing two paths to freedom and its relation to community. This work is addressed to philosophers of law, political theorists, constitutional lawyers, and everyone interested in protecting human rights and learning the meaning of human personality and freedom as expressed in democratic constitutional regimes. Eberle challenges current thinking in the field by setting out alternative visions of human freedom, dignity, personality and expression; demonstrating that use of comparative methodology has much to offer critical examination of major constitutional and public policy issues; and showing that different conceptions of fundamental ideas are possible. Exploring the nature of human personality as reflected in the constitutional law of two important constitutional democracies, Eberle inquires into human values and human freedom, across national borders, in pursuit of a better understanding of human potential and the nature and limit of freedom. The central personality traits examined comprise human dignity; autonomy; self-determination and identity, including privacy, computer privacy, control over personal information, and maintenance of one's image, words, and reputation; abortion; and freedom of expression, including defamation, offensive speech, hate speech, and burning of the flag. The book weaves between German and American law in examining these questions, providing a unique comparative perspective on the idea of human personality and freedom.

A Review of Various Actions by the Federal Bureau of Investigation and Department of Justice in Advance of the 2016 Election... A Review of Various Actions by the Federal Bureau of Investigation and Department of Justice in Advance of the 2016 Election (Hardcover)
Office of the Inspector General, U.S. Department of Justice
R1,050 Discovery Miles 10 500 Ships in 18 - 22 working days
Legal Perspectives on Equal Treatment and Non-Discrimination - Studies in Employment and Social Policy (Hardcover): Ann... Legal Perspectives on Equal Treatment and Non-Discrimination - Studies in Employment and Social Policy (Hardcover)
Ann Numhauser-Henning
R4,540 Discovery Miles 45 400 Out of stock

The non-discrimination principle enshrined in the Treaty of Rome has grown, through the case law of the European Court of Justice, into a normative core of the utmost importance for the totality of Community law. In particular, the equal treatment doctrine which developed from the application of non-discrimination in employment continues to challenge the legal structures of labour law and European social integration. This collection of essays on the current and future state of equal treatment and non-discrimination in EC law presents the proceedings of a conference held at Lund University in December 2000, sponsored by the Norma Research Programme, which studies normative patterns and their development in the legal regulation of employment, housing, family and social security from a European integration perspective. Important areas of discussion include the following, among many other topics: indirect discrimination, defining the protected group, pregnancy discrimination, positive action, flexibilization of working life, rights of contract workers, and reasonable adjustments for workers with disabilities. In an interesting outcome, the discussion reveals that an analysis in terms of discrimination adds to our understanding of law even in areas that are not generally articulated in such terms. In the wake of the European Charter of Fundamental Rights, and in the light of the distinct possibility that Europe may be moving toward a "Single Non-Discrimination/Equal Treatment Act", this is a fruitful point of view - one of many insights that should make this book a useful source of material with which practitioners, academics, and other interested professionals can further the development of the equal treatment principle in European law.

Curious Cases of Flagellation in France - Considered From a Legal, Medical and Historical Standpoint With Reference to... Curious Cases of Flagellation in France - Considered From a Legal, Medical and Historical Standpoint With Reference to Analogous Cases in England, Germany, Italy, America, Australia and the Soudan (Hardcover)
Anonymous
R885 Discovery Miles 8 850 Ships in 10 - 15 working days
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Hardcover, 2nd ed.): Amiram Daniel The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Hardcover, 2nd ed.)
Amiram Daniel
R2,208 Discovery Miles 22 080 Ships in 18 - 22 working days

How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.

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