European Medical Device Regulation (MDR) for MedTech and Medical Device Manufacturers


Book Description

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.




Public Health Effectiveness of the FDA 510(k) Clearance Process


Book Description

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.




Health Technology Assessment of Medical Devices


Book Description

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.




The Changing Economics of Medical Technology


Book Description

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.




Registries for Evaluating Patient Outcomes


Book Description

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.




Medical Device Regulatory Practices


Book Description

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




Measuring Regulatory Performance A Practitioner's Guide to Perception Surveys


Book Description

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.




Additive Manufacturing of Metals


Book Description

This engaging volume presents the exciting new technology of additive manufacturing (AM) of metal objects for a broad audience of academic and industry researchers, manufacturing professionals, undergraduate and graduate students, hobbyists, and artists. Innovative applications ranging from rocket nozzles to custom jewelry to medical implants illustrate a new world of freedom in design and fabrication, creating objects otherwise not possible by conventional means. The author describes the various methods and advanced metals used to create high value components, enabling readers to choose which process is best for them. Of particular interest is how harnessing the power of lasers, electron beams, and electric arcs, as directed by advanced computer models, robots, and 3D printing systems, can create otherwise unattainable objects. A timeline depicting the evolution of metalworking, accelerated by the computer and information age, ties AM metal technology to the rapid evolution of global technology trends. Charts, diagrams, and illustrations complement the text to describe the diverse set of technologies brought together in the AM processing of metal. Extensive listing of terms, definitions, and acronyms provides the reader with a quick reference guide to the language of AM metal processing. The book directs the reader to a wealth of internet sites providing further reading and resources, such as vendors and service providers, to jump start those interested in taking the first steps to establishing AM metal capability on whatever scale. The appendix provides hands-on example exercises for those ready to engage in experiential self-directed learning.




Bio- and MedTech Entrepreneurship


Book Description

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




Medical Device Regulations Roadmap


Book Description

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)