Download or read book Impact of Medical Device Regulation on Jobs and Patients written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2017-12-20 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: Impact of medical device regulation on jobs and patients : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, February 17, 2011.
Download or read book Impact of Medical Device Regulation on Jobs and Patients written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2011 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Impact of Medical Device Regulation on Jobs and Patients written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2011 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Impact of Medical Device and Drug Regulation on Innovation Jobs and Patients written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2012 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Impact of Medical Device and Drug Regulation on Innovation Jobs and Patients written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2017-12-14 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: The impact of medical device and drug regulation on innovation, jobs, and patients : a local perspective : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, September 26, 2011.
Download or read book Regulatory Reform Series Part 5 FDA Medical Device Regulation Impact on American Patients Innovation and Jobs written by and published by . This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Impact of Medical Device and Drug Regulation on Innovation Jobs and Patients written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and published by . This book was released on 2012 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Comparative Analysis of Medical Device Regulations in the EU and the USA written by Ann-Marie Jahn and published by GRIN Verlag. This book was released on 2016-01-12 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bachelor Thesis from the year 2012 in the subject Economy - Health Economics, grade: First, Berlin School of Economics and Law, language: English, abstract: Innovations in the medical device industry have improved the health of the world population with the ability to better diagnose, prevent, predict and cure illnesses. The number of medical devices on the market is increasing exponentially, together with the complexity, diversity and technical variation of such products. In light of its impact on patient health, regulation of medical devices is necessary to ensure that safe and effective products enter the marketplace, and that the product’s benefit to the patient population outweighs its potential risks. Although there has been increasing public scrutiny of health care reform, medical devices and their global regulation has been a minor field of health economic studies. This study examines the medical device regulatory systems and its impact on health care economics, exemplarily on the legislative programs of two major markets - the United States (U.S.) and European Union (EU). Modern medical device technology dates its origin to the early 19th century, but has grown most significantly in the last 50 years (Banta, p. 15). Today, 10,000 different families of medical device types exist with more than 400,000 different individual products on the market (Eucomed 2011). Outstanding developments have included heart-lung machines, artificial joints, as well as radiographic imaging and the means to perform advanced brain surgery. The medical device technology sector is extremely innovative, with seven out of ten major medical innovations in the last 40 years coming from this field (Fuchs, Sox, JR. 2001). Despite these technological advances, medical devices sometimes fail during use and can actually result in patient harm. The purpose of regulating medical equipment is to minimize the risk of harm to the end user and to prevent potentially unsafe products from entering the marketplace. The main obstacle in developing and implementing effective regulation is the term safety itself, as it can hardly be measured and there is no formula that can be consistently applied. Guidelines have been established that measure product risk, mitigate risks where possible, and then evaluate the residual risks to determine which are acceptable. This means by implication that acceptance of risk is part of the regulation process in order to bring life-saving technologies with unknown long-term effects to the market.
Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Download or read book The Medical Device Industry written by Norman F. Estrin and published by CRC Press. This book was released on 1990-08-31 with total page 1020 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Development of Medical Devices written by Dirk Lanzerath and published by . This book was released on 2020 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Managing Medical Devices within a Regulatory Framework written by Beth Ann Fiedler and published by Elsevier. This book was released on 2016-09-10 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. - Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices - Provides operational and clinical practice recommendations in regard to regulatory changes for risk management - Discusses best practices for equipment procurement and maintenance - Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices
Download or read book A Fresh Look at the Impact of the Medical Device Tax on Jobs Innovation and Patients written by United States. Congress and published by Createspace Independent Publishing Platform. This book was released on 2017-11-22 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: A fresh look at the impact of the medical device tax on jobs, innovation, and patients : hearing before the Subcommittee on Health Care of the Committee on Finance, United States Senate, One Hundred Fourteenth Congress, first session, April 23, 2015.
Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Download or read book Activity Report of the Committee on Energy and Commerce of the U S House of Representatives Together with Dissenting Views written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 2011 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Medical Device R D Handbook written by Theodore R. Kucklick and published by CRC Press. This book was released on 2012-12-05 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designer
