Mastering and Managing the FDA Maze: Medical Device Overview : a Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration

ASQ Quality Press
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There is a mountain of information on FDA regulation and compliance for medical device manufacturers. the task is daunting and very few busy manufacturers are regulatory mountain climbers. Reading the regulations provides only a small part of the picture. Understanding what the regulations mean and how compliance can be achieved in your environment is key. Graphic icons organize the text and provide a visual aid to definitions, regulations, procedures, documents, records, and points to remember. Applicable chapters also end with a FDA Investigator Icon, which summarizes what the FDA investigator will expect to see during an investigation.
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Additional Information

Publisher
ASQ Quality Press
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Published on
Jan 1, 1999
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Pages
289
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ISBN
9780873894555
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Best For
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Language
English
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Genres
Law / Medical Law & Legislation
Medical / Prosthesis
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Content Protection
This content is DRM protected.
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Eligible for Family Library

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Big Data: A Business and Legal Guide supplies a clear understanding of the interrelationships between Big Data, the new business insights it reveals, and the laws, regulations, and contracting practices that impact the use of the insights and the data. Providing business executives and lawyers (in-house and in private practice) with an accessible primer on Big Data and its business implications, this book will enable readers to quickly grasp the key issues and effectively implement the right solutions to collecting, licensing, handling, and using Big Data.

The book brings together subject matter experts who examine a different area of law in each chapter and explain how these laws can affect the way your business or organization can use Big Data. These experts also supply recommendations as to the steps your organization can take to maximize Big Data opportunities without increasing risk and liability to your organization.

Provides a new way of thinking about Big Data that will help readers address emerging issues Supplies real-world advice and practical ways to handle the issues Uses examples pulled from the news and cases to illustrate points Includes a non-technical Big Data primer that discusses the characteristics of Big Data and distinguishes it from traditional database models

Taking a cross-disciplinary approach, the book will help executives, managers, and counsel better understand the interrelationships between Big Data, decisions based on Big Data, and the laws, regulations, and contracting practices that impact its use. After reading this book, you will be able to think more broadly about the best way to harness Big Data in your business and establish procedures to ensure that legal considerations are part of the decision.

NEW YORK TIMES BESTSELLER • A NEW YORK TIMES NOTABLE BOOK • America’s Bitter Pill is Steven Brill’s acclaimed book on how the Affordable Care Act, or Obamacare, was written, how it is being implemented, and, most important, how it is changing—and failing to change—the rampant abuses in the healthcare industry. It’s a fly-on-the-wall account of the titanic fight to pass a 961-page law aimed at fixing America’s largest, most dysfunctional industry. It’s a penetrating chronicle of how the profiteering that Brill first identified in his trailblazing Time magazine cover story continues, despite Obamacare. And it is the first complete, inside account of how President Obama persevered to push through the law, but then failed to deal with the staff incompetence and turf wars that crippled its implementation.
 
But by chance America’s Bitter Pill ends up being much more—because as Brill was completing this book, he had to undergo urgent open-heart surgery. Thus, this also becomes the story of how one patient who thinks he knows everything about healthcare “policy” rethinks it from a hospital gurney—and combines that insight with his brilliant reporting. The result: a surprising new vision of how we can fix American healthcare so that it stops draining the bank accounts of our families and our businesses, and the federal treasury.
 
Praise for America’s Bitter Pill
 
“A tour de force . . . a comprehensive and suitably furious guide to the political landscape of American healthcare . . . persuasive, shocking.”—The New York Times
 
“An energetic, picaresque, narrative explanation of much of what has happened in the last seven years of health policy . . . [Brill] has pulled off something extraordinary.”—The New York Times Book Review
 
“A thunderous indictment of what Brill refers to as the ‘toxicity of our profiteer-dominated healthcare system.’ ”—Los Angeles Times
 
“A sweeping and spirited new book [that] chronicles the surprisingly juicy tale of reform.”—The Daily Beast
 
“One of the most important books of our time.”—Walter Isaacson
 
“Superb . . . Brill has achieved the seemingly impossible—written an exciting book about the American health system.”—The New York Review of Books
Pediatric Life Care Planning and Case Management provides a comprehensive and unique reference that goes beyond the clinical discussion to include legal and financial aspects, life expectancy data, and assistive technology. It also includes case samples of actual plans related to specific conditions.

The book is divided into five parts:

Normal Growth and Development of Children describes the normal growth and development and the cognitive and psychosocial development of children.

The Roles of the Life Care Plan Team details the roles of members of a life care plan team, from the pediatric care manager and life care planner to the vocational rehabilitation consultant, among others.

Chronic Conditions and Disability States offers guidelines for life care planning for children with a wide range of chronic health conditions and disabilities, including traumatic injuries and organ transplants.

Forensic Considerations examines life care planning in legal cases, life expectancy issues, and life care plan foundation strategies and requirements.

Special Issues discusses assistive technology, medical homes, funding sources, and ethical issues in caring for children with special needs—including a mother’s perspective on caring for her son.

With contributions from highly respected professionals, this text provides a guide for life care planners, health-care professionals, education specialists, insurance decision makers, attorneys, and families who work with children with special health-care needs.

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