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European Medical Device Regulation Mdr For Medtech And Medical Device Manufacturers
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Book Synopsis European Medical Device Regulation (MDR) for MedTech and Medical Device Manufacturers by : Des O'Brien
Download or read book European Medical Device Regulation (MDR) for MedTech and Medical Device Manufacturers written by Des O'Brien and published by . This book was released on 2019-04-05 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: The new European regulations on medical devices and in vitro medical devices were adopted on 05 April 2017 and came into force on 25th May 2017. Both these 2 new regulations replace and repeal Council Directives 90/385/EEC, 93/42/EEC Directive 98/79/EC and Commission Decision 2010/227/EU. This short book (approx 120 pages) provides a foundation overview of the new regulations and how they are structured. It must be stated that many notified bodies and companies provide insight and guidance online, this book provides a tangible resource for day to day use or for gaining an introduction to EU MDR, or alternatively as an ongoing quick reference guide. Although adopted and in force, the new rules shall only apply after a 3-year transitional period, whereby regulations will enter into force in April 2020 for medical devices and for five years after entry into force (April 2022) for the Regulation on in-vitro diagnostic medical devices.
Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Book Synopsis The Changing Economics of Medical Technology by : Institute of Medicine
Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author :World Health Organization Publisher :Who Medical Device Technical ISBN 13 :9789241501361 Total Pages :39 pages Book Rating :4.5/5 (13 download)
Book Synopsis Health Technology Assessment of Medical Devices by : World Health Organization
Download or read book Health Technology Assessment of Medical Devices written by World Health Organization and published by Who Medical Device Technical. This book was released on 2012-10-25 with total page 39 pages. Available in PDF, EPUB and Kindle. Book excerpt: WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. HTA is the systematic evaluation of properties, effects, and/or impacts of health technology. Its main purpose is to inform technology-related policy-making in health care, and thus improve the uptake of cost-effective new technologies and prevent the uptake of technologies that are of doubtful value for the health system. It is one of three complementary functions to ensure the appropriate introduction and use of health technology. The other two components are regulation, which is concerned with safety and efficacy, and assessment of all significant intended as well as unintended consequences of technology use; and management, which is concerned with the procurement and maintenance of the technology during its life-cycle. The performance of health systems is strengthened when the linkages and exchange among these elements are clearly differentiated but mutually supportive. This document integrates health technology assessment into the WHO framework for evidence-informed policy-making. Health systems are strengthened when HTA is integrated into the human and material resources, data, transparent decision- and policy-making, and linked to the overall vision of equity and accountability. Good governance can rely on health technology assessment to provide a policy approach that is accountable for its decisions to the population.
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :385 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Book Synopsis Medical Device Regulatory Practices by : Val Theisz
Download or read book Medical Device Regulatory Practices written by Val Theisz and published by CRC Press. This book was released on 2015-08-03 with total page 578 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effectiv
Book Synopsis Measuring Regulatory Performance A Practitioner's Guide to Perception Surveys by : OECD
Download or read book Measuring Regulatory Performance A Practitioner's Guide to Perception Surveys written by OECD and published by OECD Publishing. This book was released on 2012-01-16 with total page 91 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide helps officials use perception surveys for evaluating and communicating progress in regulatory reform. It explains the challenges involved in the design and use of business and citizen perception surveys – and ways to overcome them.
Book Synopsis Handbook of Human Factors in Medical Device Design by : Matthew Bret Weinger
Download or read book Handbook of Human Factors in Medical Device Design written by Matthew Bret Weinger and published by CRC Press. This book was released on 2010-12-13 with total page 822 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance
Book Synopsis Clinical Evaluation of Medical Devices by : Karen M. Becker
Download or read book Clinical Evaluation of Medical Devices written by Karen M. Becker and published by Springer Science & Business Media. This book was released on 2007-11-05 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: The original edition of this text, Clinical Evaluation of Medical Devices: Principles and Case Studies, provided the first overview of key pr- ciples and approaches to medical device clinical trials, illustrated with a series of detailed, real-world case studies. The book is designed as a resource for clinical professionals and regulatory specialists working in the field of new medical device development and marketing. Since the first edition of this text was published in 1997, the rapid pace of inno- tion in health care technologies continues to yield exciting and important new products. The regulatory landscape has also evolved, reflecting some of the changes and needs within the medical device industry. The purpose of Clinical Evaluation of Medical Devices: Principles and Case Studies, Second Edition is to provide an updated and expanded presentation of the scientific methods and regulatory requirements applied to the study of new significant risk medical devices. The text now includes (1) new information on the requirements and process for gaining reimbursement of new products from Medicare and private insurers, with case studies of research specifically designed for this p- pose as well as health care technology assessment methods; (2) infor- tion on new statistical methodologies applied to medical device trials; and (3) all new case studies, including examples of combination pr- ucts, three-phase development models (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel study designs.
Book Synopsis Bio- and MedTech Entrepreneurship by : Heidrun Flaadt Cervini
Download or read book Bio- and MedTech Entrepreneurship written by Heidrun Flaadt Cervini and published by Stämpfli Verlag. This book was released on 2020-07-21 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: The process of innovation in life science is capital intensive, associated with a high risk as well as highly regulated and is therefore distinct from other types of innovation. This book closes the educational gap in life science entrepreneurship and fills a market niche. It allows you to understand, manage and successfully lead the innovation process in life science. Learn how to develop and successful market biomedical technology Increase the return of your investments in biomedical innovation Get ready for a new career in a life science start-up Discover how to transfer a bio- or medtech project from academia to industry Obtain a comprehensive overview of the innovation process in life science
Book Synopsis Springer Handbook of Medical Technology by : Rüdiger Kramme
Download or read book Springer Handbook of Medical Technology written by Rüdiger Kramme and published by Springer Science & Business Media. This book was released on 2011-10-02 with total page 1503 pages. Available in PDF, EPUB and Kindle. Book excerpt: This concise, user-oriented and up-to-date desk reference offers a broad introduction to the fascinating world of medical technology, fully considering today’s progress and further development in all relevant fields. The Springer Handbook of Medical Technology is a systemized and well-structured guideline which distinguishes itself through simplification and condensation of complex facts. This book is an indispensable resource for professionals working directly or indirectly with medical systems and appliances every day. It is also meant for graduate and post graduate students in hospital management, medical engineering, and medical physics.
Book Synopsis Artificial Intelligence in Healthcare by : Adam Bohr
Download or read book Artificial Intelligence in Healthcare written by Adam Bohr and published by Academic Press. This book was released on 2020-06-21 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. - Highlights different data techniques in healthcare data analysis, including machine learning and data mining - Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks - Includes applications and case studies across all areas of AI in healthcare data
Book Synopsis Medical Device Regulations Roadmap by : Des O'Brien
Download or read book Medical Device Regulations Roadmap written by Des O'Brien and published by Createspace Independent Publishing Platform. This book was released on 2017-10-11 with total page 112 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the Engineer or scientist starting out in Medical devices, the array of regulation across the globe can be daunting. Many companies also need to fulfill regulation from multiple jurisdictions. Some requirements of Design, GMP and manufacturing are common. FDA and European market requires provide a framework for medical device manufacturers to certain requirements that ensure patient safety. This short book introduces the key themes associated with Medical Device Regulation. While the online world provides a detailed and perrinial source of current information and regulations, it is often hard to know where to start. This concise book provides that introduction and provides in a physical format that is a useful companion for the Engineer or Medical Device Professional. (Page Count 112)
Book Synopsis High Performance Technical Textiles by : Roshan Paul
Download or read book High Performance Technical Textiles written by Roshan Paul and published by John Wiley & Sons. This book was released on 2019-02-19 with total page 503 pages. Available in PDF, EPUB and Kindle. Book excerpt: An authentic resource for the fundamentals, applied techniques, applications and recent advancements of all the main areas of technical textiles Created to be a comprehensive reference, High Performance Technical Textiles includes the review of a wide range of technical textiles from household to space textiles. The contributors—noted experts in the field from all the continents—offer in-depth coverage on the fibre materials, manufacturing processes and techniques, applications, current developments, sustainability and future trends. The contributors include discussions on synthetic versus natural fibres, various textile manufacturing techniques, textile composites and finishing approaches that are involved in the manufacturing of textiles for a specific high performance application. Whilst the book provides the basic knowledge required for an understanding of technical textiles, it can serve as a springboard for inspiring new inventions in hi-tech fibres and textiles. This important book: Contains a unique approach that offers a comprehensive understanding of the manufacturing and applications of technical textiles Includes a general overview to the fundamentals, current techniques, end use applications as well as the most recent advancements Explores the current standards in the industry and the ongoing research in the field Offers a comprehensive and single source reference on the topic Written for academics, researchers and professionals working in textile and related industries, High Performance Technical Textiles offers a systematic, structured, logical and updated source of information for understanding technical textiles.
Book Synopsis The Design and Manufacture of Medical Devices by : J. Paulo Davim
Download or read book The Design and Manufacture of Medical Devices written by J. Paulo Davim and published by Elsevier. This book was released on 2012-10-16 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices play an important role in the field of medical and health technology, and encompass a wide range of health care products. Directive 2007/47/EC defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. The design and manufacture of medical devices brings together a range of articles and case studies dealing with medical device R&D. Chapters in the book cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems. - Contains articles on a diverse range of subjects within the field, with internationally renowned specialists discussing each medical device - Offers a practical approach to recent developments in the design and manufacture of medical devices - Presents a topic that is the focus of research in many important universities and centres of research worldwide
Book Synopsis Referral Guidelines for Imaging by : European Commission. Environment Directorate-General
Download or read book Referral Guidelines for Imaging written by European Commission. Environment Directorate-General and published by . This book was released on 2001 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This booklet sets out referral guidelines that can be used by health professionals qualified to refer patients for imaging. It has evolved from the booklet 'Making the best use of a department of clinical radiology: guidelines for doctors' published by the Royal College of Radiologists in 1998 and can be adopted as a model for Member States. The EU Council Directive 1997/43/EURATOM declared that Member States shall promote the establishment and use of diagnostic reference levels for radiological examinations and guidance thereof. These referral guidelines can be used for that purpose.
Book Synopsis The Medical Devices (Amendment Etc. ) (EU Exit) Regulations 2020 by : GREAT BRITAIN.
Download or read book The Medical Devices (Amendment Etc. ) (EU Exit) Regulations 2020 written by GREAT BRITAIN. and published by . This book was released on 2020-10-16 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt: Enabling power: European Union (Withdrawal) Act 2018, ss. 8 (1), 8C, sch. 4, para. 1 (1) (ab), 7 (2), sch. 7, para. 21 & European Union (Withdrawal Agreement) Act 2020, s. 41 (1). Issued: 16.10.2020. Sifted: -. Made: -. Laid: -. Coming into force: In accord. with reg. 1 (2) (3). Effect: S.I. 2002/618; 2019/791, 1385 amended. Territorial extent & classification: E/W/S/NI. EC note: Directive 90/385; 93/42; 98/79 modified. For approval by resolution of each House of Parliament
