Medical Devices Law And Regulation Answer Book 2015

Author : Suzan Onel,Karen M. Becker
Publisher : Unknown
Page : 0 pages
File Size : 47,6 Mb
Release : 2014-10-07
Category : Medical instruments and apparatus
ISBN : 1402422601

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Medical Devices Law and Regulation Answer Book 2015 by Suzan Onel,Karen M. Becker Pdf

The regulation of medical devices has grown increasingly complex since the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) were introduced in 1976. This title walks you through the current regulatory requirements and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. Topics include: Overview of Medical Device Regulation in the U.S; Clinical Studies of Investigational Devices; Device Premarket Submissions; Devices with Unique Issues Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software; Licensing, Product Development and Commercialization * FDA Criminal Enforcement * Overlapping Jurisdiction with other Agencies and Law Enforcement Entities * Commonly Used Acronyms"

Author : Suzan Onel,Karen M. Becker
Publisher : Unknown
Page : 128 pages
File Size : 53,6 Mb
Release : 2020
Category : Medical instruments and apparatus
ISBN : OCLC:1198232423

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Medical Devices Law and Regulation Answer Book by Suzan Onel,Karen M. Becker Pdf

Author : Suzan Onel,Karen M. Becker
Publisher : Unknown
Page : 1220 pages
File Size : 50,5 Mb
Release : 2018-11-06
Category : Law
ISBN : 1402431368

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Medical Devices Law and Regulation Answer Book by Suzan Onel,Karen M. Becker Pdf

In Medical Devices Law and Regulation Answer Book, more than thirty contributors from various law and consulting firms share their expertise regarding the laws and regulations governing medical devices. This book provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations. It provides practical guidance on how to handle everyday questions on a wide variety of topics, as well as what issues are likely to arise and how to avoid them. This question-and-answer guide also discusses related topics that have a marked impact on the medical devices industry, such as intellectual property, product liability, and reimbursement.The Medical Devices Law and Regulation Answer Book is designed to distill the essential elements of this complex regulatory environment and provide in a single resource a practical guide to the complexities of FDA regulation of medical devices. It is a practical in-depth reference for all lawyers, consultants, and companies operating in the medical devices sector, as well as all companies contemplating entry into the heavily regulated world of medical devices.

Author : Karen Becker,Suzan Onel
Publisher : Practising Law Inst
Page : 960 pages
File Size : 45,8 Mb
Release : 2011
Category : Law
ISBN : 1402416385

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Medical Devices Law and Regulation Answer by Karen Becker,Suzan Onel Pdf

Author : Suzan Onel,Karen Becker
Publisher : Practising Law Inst
Page : 1014 pages
File Size : 43,5 Mb
Release : 2012
Category : Law
ISBN : 140241837X

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Medical Devices Law and Regulation Answer by Suzan Onel,Karen Becker Pdf

The regulation of medical devices has grown increasingly complex since the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) were introduced in 1976. Medical Devices Law and Regulation Answer Book 2013 walks you through the current regulatory requirements and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. With over 30 contributors from a variety of major law firms and consulting firms specializing in medical device work, Medical Devices Law and Regulation Answer Book 2013 provides practical guidance on how to handle every day questions on a wide variety of topics as well as what issues are likely to arise and how to avoid them. The breadth of coverage of this new publication is illustrated by the chapter titles provided below: Overview of Medical Device Regulation in the U.S. Clinical Studies of Investigational Devices Device Premarket Submissions Devices with Unique Issues Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software In Vitro Diagnostic (IVD) Devices The Quality System Regulation Device Facility Inspections Post Market Considerations International Considerations Enforcement and Government Investigations Regarding Medical Devices Interacting with FDA Intellectual Property Considerations for Medical Device Companies Fraudulent and Abusive Practices in the Reimbursement for Medical Devices HIPAA s Impact on the Medical Device Manufacturing Community Continuing Medical Education (CME) and Industry-Supported Scientific Activities Litigation, Product Liability, and Preemption Licensing, Product Development and Commercialization FDA Criminal Enforcement Overlapping Jurisdiction with other Agencies and Law Enforcement Entities Commonly Used Acronyms"

Author : Suzan Onel,Karen M. Becker
Publisher : Unknown
Page : 0 pages
File Size : 48,9 Mb
Release : 2013-11-07
Category : Medical instruments and apparatus
ISBN : 1402420498

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Medical Devices Law and Regulation Answer Book 2014 by Suzan Onel,Karen M. Becker Pdf

The regulation of medical devices has grown increasingly complex since the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (FDCA) were introduced in 1976. This title walks you through the current regulatory requirements and describes every aspect from pre-market requirements for specific types of devices to post-market regulation and ongoing government enforcement and investigation. Topics include: Overview of Medical Device Regulation in the U.S; Clinical Studies of Investigational Devices ; Device Premarket Submissions; Devices with Unique Issues - Combination Devices, Radiological Devices, Restricted Devices, Customer Devices, Device Software; Licensing, Product Development and Commercialization * FDA Criminal Enforcement * Overlapping Jurisdiction with other Agencies and Law Enforcement Entities * Commonly Used Acronyms"

Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publisher : Woodhead Publishing
Page : 256 pages
File Size : 55,7 Mb
Release : 2015-08-18
Category : Medical
ISBN : 9780081002919

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Medical Devices by Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo Pdf

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process

Author : Aakash Deep
Publisher : Academic Press
Page : 187 pages
File Size : 53,7 Mb
Release : 2022-01-13
Category : Technology & Engineering
ISBN : 9780323911276

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Medical Device Regulations by Aakash Deep Pdf

Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products

Author : Richard C. Fries
Publisher : CRC Press
Page : 490 pages
File Size : 45,8 Mb
Release : 2005-11-21
Category : Medical
ISBN : 9781420027945

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Reliable Design of Medical Devices by Richard C. Fries Pdf

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Author : John J. Tobin,Gary Walsh
Publisher : John Wiley & Sons
Page : 304 pages
File Size : 49,7 Mb
Release : 2011-08-24
Category : Science
ISBN : 9783527644711

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Medical Product Regulatory Affairs by John J. Tobin,Gary Walsh Pdf

Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.

Author : Almir Badnjević,Mario Cifrek,Ratko Magjarević,Zijad Džemić
Publisher : Springer Nature
Page : 441 pages
File Size : 42,9 Mb
Release : 2023-12-28
Category : Technology & Engineering
ISBN : 9783031434440

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Inspection of Medical Devices by Almir Badnjević,Mario Cifrek,Ratko Magjarević,Zijad Džemić Pdf

This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!

Author : G.R Higson
Publisher : CRC Press
Page : 278 pages
File Size : 50,8 Mb
Release : 2001-10-29
Category : Medical
ISBN : 9781420033984

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Medical Device Safety by G.R Higson Pdf

Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en

Author : Carl T. DeMarco
Publisher : Quality Press
Page : 369 pages
File Size : 46,5 Mb
Release : 2011-01-24
Category : Medical
ISBN : 9780873891882

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Medical Device Design and Regulation by Carl T. DeMarco Pdf

The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use or for employee training. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the “MDDR Users Group” on LinkedIn.

Author : Jonathan S. Kahan,Barnett International,Parexel International Corporation
Publisher : Unknown
Page : 622 pages
File Size : 48,8 Mb
Release : 2014-03-01
Category : Medical instruments and apparatus
ISBN : 0988314436

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Medical Device Development by Jonathan S. Kahan,Barnett International,Parexel International Corporation Pdf

Author : Michael Cheng,World Health Organization
Publisher : Diamond Pocket Books (P) Ltd.
Page : 58 pages
File Size : 50,5 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9241546182

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Medical Device Regulations by Michael Cheng,World Health Organization Pdf

The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.