Definition of Product; Definitions of Defect, Including Restatement 2d Torts and Restatement 3d Product Liability; Definition of Sale; Breakdown of Privity; Statutory Violations; Bases of Liability Including Negligence, Warranty and Strict Liability; Potential Plaintiffs; Potential Defendants Including Manufacturers, Distributors, Lessors, Realtors, Successor Corporations and Providers of Services; Contribution and Indemnity; Reliance; Disclaimers; Solely Economic Loss; Notice of Breach; Jurisdiction; Statutory Compliance; Contract Specifications Defense; Statutes of Limitations; Statutory Changes; Production, Design and Warning Claims; Misrepresentation; Causation; Subsequent Remedial Measures; Spoliation; Expert Testimony.
This book provides an overview of products liability law, organizing and explaining the essential history, developments, policies, and tensions of this field of law succinctly yet comprehensively. An abridgment of Professor Owen's acclaimed hornbook treatise, this short work examines classic and recent case and other developments in products liability law, including theories of liability; definitions and proof of product defects; standards for expert testimony; the assault on strict liability by the state-of-the-art doctrine; federal preemption and other defenses; and the Restatement of the Law of Torts, Third: Products Liability.
As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What’s New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.
Author: Paul H. King,Richard C. Fries,Arthur T. Johnson
Publisher: CRC Press
This will be a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter will be thoroughly updated and revised to reflect the latest developments. New material will be added on entrepreneurship, bioengineering statistics, clinical trials and CRISPR. New examples, applications and problems will be added in each chapter.There will be strong efforts made to increase the number of clinical applications to enhance the overall relevance of the material that's presented. Significant new material added on FDA regulations.
Apply a Wide Variety of Design Processes to a Wide Category of Design Problems Design of Biomedical Devices and Systems, Third Edition continues to provide a real-world approach to the design of biomedical engineering devices and/or systems. Bringing together information on the design and initiation of design projects from several sources, this edition strongly emphasizes and further clarifies the standards of design procedure. Following the best practices for conducting and completing a design project, it outlines the various steps in the design process in a basic, flexible, and logical order. What’s New in the Third Edition: This latest edition contains a new chapter on biological engineering design, a new chapter on the FDA regulations for items other than devices such as drugs, new end-of-chapter problems, new case studies, and a chapter on product development. It adds mathematical modeling tools, and provides new information on FDA regulations and standards, as well as clinical trials and sterilization methods. Familiarizes the reader with medical devices, and their design, regulation, and use Considers safety aspects of the devices Contains an enhanced pedagogy Provides an overview of basic design issues Design of Biomedical Devices and Systems, Third Edition covers the design of biomedical engineering devices and/or systems, and is designed to support bioengineering and biomedical engineering students and novice engineers entering the medical device market.
Wollen Sie auch die umfangreichen Möglichkeiten von R nutzen, um Ihre Daten zu analysieren, sind sich aber nicht sicher, ob Sie mit der Programmiersprache wirklich zurechtkommen? Keine Sorge - dieses Buch zeigt Ihnen, wie es geht - selbst wenn Sie keine Vorkenntnisse in der Programmierung oder Statistik haben. Andrie de Vries und Joris Meys zeigen Ihnen Schritt für Schritt und anhand zahlreicher Beispiele, was Sie alles mit R machen können und vor allem wie Sie es machen können. Von den Grundlagen und den ersten Skripten bis hin zu komplexen statistischen Analysen und der Erstellung aussagekräftiger Grafiken. Auch fortgeschrittenere Nutzer finden in diesem Buch viele Tipps und Tricks, die Ihnen die Datenauswertung erleichtern.
In seinem Kultbuch „Eine kurze Geschichte der Menschheit“ erklärte Yuval Noah Harari, wie unsere Spezies die Erde erobern konnte. In „Homo Deus“ stößt er vor in eine noch verborgene Welt: die Zukunft. Was wird mit uns und unserem Planeten passieren, wenn die neuen Technologien dem Menschen gottgleiche Fähigkeiten verleihen – schöpferische wie zerstörerische – und das Leben selbst auf eine völlig neue Stufe der Evolution heben? Wie wird es dem Homo Sapiens ergehen, wenn er einen technikverstärkten Homo Deus erschafft, der sich vom heutigen Menschen deutlicher unterscheidet als dieser vom Neandertaler? Was bleibt von uns und der modernen Religion des Humanismus, wenn wir Maschinen konstruieren, die alles besser können als wir? In unserer Gier nach Gesundheit, Glück und Macht könnten wir uns ganz allmählich so weit verändern, bis wir schließlich keine Menschen mehr sind.
A down-to-earth approach to governance, risk and compliance
Author: Dawn Pretorius
Publisher: Xlibris Corporation
Category: Business & Economics
There is a lot of information available on governance, risk and compliance as separate subjects but little on the interrelation between the three components known in the industry as enterprise-wide governance, risk and compliance (eGRC). This book brings eGRC to the reader in a way that starts with simple concepts and builds on them to provide insight and a practical guide for a holistic approach to eGRC. Companies have to manage risk in order to remain a sustainable force in the marketplace. Efforts to reduce risk can, unintentionally, be uncoordinated, disjointed or even neglected. Through not implementing a more cohesive and systematic approach to managing risk, opportunities to benefit the company can also be missed. Beyond Play offers a practical and simple approach. Compliance is a very specific form of risk: that of complying with the law, but the role of the compliance officer includes a lot more. Working with the law and regulators and applying a compliance methodology are explained to provide value to learners, compliance officers, managers, prescribed officers and directors. Many companies ‘play’ at corporate governance, probably because it is perceived as being ‘too big’ to grasp. This book will change your thinking and will help directors’ pave the way for implementing a framework that can be worked with on a practical level within an enterprise wide risk management context. The systemic nature of risk means it can spread to customers, shareholders, communities and economies as the credit bubble of 2008 has proved. Equally, a company that applies a robust an intelligent approach to eGRC has a positive influence on the marketplace, the community and a nation. Do you believe that your business, whether for profit or not for profit and on the basis on which it currently operates, is sustainable in an increasingly dynamic world? This book uses examples from the financial services industry; it also makes reference to South African legislation and governance codes. These references do, however, focus on international best practices so the methodologies can be universally applied. Governance, risk and compliance is an integrated concept to be incorporated within an enterprise risk framework which helps an organisation, either private or public, for profit or non profit, to direct its strategies and operations with integrity and within the law; the reason being to achieve its goals in such a way that its stakeholders and the economy as a whole are never compromised or put at risk beyond that which has been carefully defined and deemed acceptable.
This product offers a compact yet comprehensive and up-to-date overview of U.S. copyright law in an uncluttered and readable format. Coverage ranges from the fundamental concepts of originality, authorship, and infringement to the highly technical rules governing digital phonorecord deliveries and digital public performance rights in sound recordings, the safe harbor provisions that limit the liability of Internet service providers, and the anti-circumvention and copyright management information provisions of the Digital Millennium Copyright Act. The evolving doctrines of fair use and contributory liability are also given thorough attention.
This work introduces the study of toxic torts and identifies the theories of liability related to both toxic products and environmental pollution. It also covers special defendants, such as employers, governmental entities, and government contractors; workers' compensation; insurance coverage issues; key defenses such as statutes of limitations and preemption; causation and scientific evidence; and new theories of injury and damages. A chapter examines regulation of hazardous releases into the environment under the federal Comprehensive Environmental Response, Compensation and Liability Act (CERCLA). The work also addresses mass toxic torts and the procedural issues that accompany them. Substantial updates include liability for "take-home" toxins; sovereign immunity under the Federal Tort Claims Act and the government contractor defense; preemption of generic drug claims; and the any-exposure theory of causation. In addition to the complete update, the Sixth Edition also contains new material on the following: Bare metal defense in asbestos litigation Talc litigation Opioid litigation Impact of U.S. Supreme Court's 2017 decision in Bristol-Myers Squibb Co. v. Superior Court on personal jurisdiction over drug manufacturers in product liability cases Impact of U.S. Supreme Court's 2016 decision in Spokeo, Inc. v. Robins on standing The 2018 proposed amendments to Fed. R. Civ. P. 23 covering class action notice and settlements Flint, Michigan, contaminated water litigation PFOA/PFOS litigation
Ein amerikanischer Botschafter in Nazi-Deutschland
Author: Erik Larson
Publisher: Hoffmann und Campe
Berlin, 1933. William E. Dodd kommt als Botschafter nach Deutschland. Zunächst recht unkritisch, verkehren er und seine Tochter Martha mit hochrangigen Nazis und besuchen deren schillernde Partys. Doch die Schatten werden immer dunkler - bis zur blutigen »Nacht der langen Messer«, in der ein Ausbruch von Gewalt und Hass endgültig Hitlers skrupellose Ambitionen offenbart. Er ist nicht Roosevelts erste Wahl, doch da sich kein anderer Kandidat findet, wird der gutmütige Geschichtsprofessor Dodd nach Berlin geschickt. Dieser muss sich nicht nur mit den merkwürdigen Entwicklungen in Deutschland auseinandersetzen, sondern auch einem intriganten, politisch gleichgültigen State Department entgegentreten. Unterdessen ist Martha verzückt von den Partys und dem Pomp - und den hübschen jungen Nazis. Doch als sich Attacken auf Juden häufen, die Presse der Zensur unterworfen wird, Entwürfe von beängstigenden Gesetzen in den Umlauf kommen und schließlich in der »Nacht der langen Messer« Hitlers wahre Absichten offenbar werden, müssen die Dodds die Gefahr erkennen. Atemberaubend temporeich erzählt, mit unvergesslichen Porträts der neuen Herren von Deutschland, zeigt das Buch aus der Perspektive von externen Augenzeugen die Machtergreifung der Nazis in einem neuen Licht - und gibt Einblick, warum die Welt die ernste Bedrohung durch Hitler erst wahrnahm, als Berlin und Europa von Blut und Terror überschwemmt wurden.
How to Engage Sweeping Change Without Killing Yourself Or Your Business
Author: Mark Morgan,Andrew Cole,Dave Johnson,Rob Johnson
Publisher: John Wiley & Sons
Category: Business & Economics
Practical, tested, implementable real-world advice for transforming any business and is written by people that have “been there and done that”. Changing an organization is tough. Transformation is hard work that should not be attempted by the faint of heart or the weak of mind. But transformation is not rocket science either. By taking a realistic, simple and direct view of what is required to transform an enterprise, the authors reduce the noise and nonsense that surrounds much of the discussion of transformation and provide straight forward lessons, examples and thought provoking questions to guide the reader to a more powerful position as an agent of change. Based on the authors' decades of experience dealing with major business transformation, this book provides valuable guidance for any company engaged in large scale change brought on by shifts in the competitive landscape, mergers, acquisitions, or a major restructuring of their business model. Many organizations undergo transformation with lots of enthusiasm, but are frustrated with the results. This book contains a set of lessons gained in the process of working in and with organizations in the process of transformation. The book starts out by framing transformation and explains the overall system the enterprise that is involved in transformation. By doing so, clarity is brought to the question of why change is so difficult and problematic. What you can expect to get by reading this book is: A way of looking at transformation that is comprehensive and yet manageable without all the buzzword bingo terminology 11 critical lessons taken from the author’s broad experience on a broad range of topics that you can leverage in your situation To get some thought provoking insight from 10 key questions for each lesson that you can use to apply the lessons to your organization A comprehensive framework for leading transformation that will challenge your thinking and provide a path forward to taking immediate action With rare insight and candor, the authors provide thoughtful advice backed by examples from their comprehensive experience. If you don’t like transformation, you are going to hate irrelevance. This book is your best bet for getting the insight you need to transform your organization before it becomes irrelevant.
The book delineates, with extraordinary clarity and precision, the working of unfair competition law throughout the European Union. Its four comprehensive chapters encompass: basic considerations of definition, subject matter, enforcement, and applicable law: international provisions under the Paris convention, TRIPS, and WIPO model law; analysis of relevant EC directives and regulations and ECJ jurisprudence; and extensive discussions of the national unfair competition laws of all 25 Member States. For each Member State, specific topics covered include such considerations as the following: sources of law; competition law in a nutshell; regulation of advertising; direct marketing; sales promotion; risk of confusion; disparagement, defamation; misappropriation, imitation; impediment of competitors; and breach of the law. The author also provides a selected bibliography of sources for each country. It would be difficult to find a more useful analysis of European Unfair Competition Law than this systematic study. It is practical, thorough, clarifying, and readable, all at the same time. The author untangles the most complex of apparent contradictions with impressive skill. Copies of this book will quickly take their places on the working shelves of interested practitioners, academics, and officials throughout Europe.