Clinical Evaluation of Medical Devices

Clinical Evaluation of Medical Devices
Author: Karen M. Becker,John J. Whyte
Publsiher: Springer Science & Business Media
Total Pages: 360
Release: 2007-11-05
Genre: Technology & Engineering
ISBN: 9781597450041

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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.

Clinical Evaluation of Medical Devices

Clinical Evaluation of Medical Devices
Author: Karen Becker Witkin
Publsiher: Unknown
Total Pages: 286
Release: 2014-01-15
Genre: Electronic Book
ISBN: 1475727577

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Clinical Evaluation and Investigation of Medical Devices under the new EU Regulation

Clinical Evaluation and Investigation of Medical Devices under the new EU Regulation
Author: Wolfgang Ecker,Gerold Labek,Tarquin Mittermayr,Brigitte Raffeiner,Michael Ring,Bernhard Schwartz
Publsiher: BoD – Books on Demand
Total Pages: 282
Release: 2020-06-04
Genre: Medical
ISBN: 9783751937665

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The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking. It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups. spin-offs or other development projects or in counselling services.

Personalized Medicine in Healthcare Systems

Personalized Medicine in Healthcare Systems
Author: Nada Bodiroga-Vukobrat,Daniel Rukavina,Krešimir Pavelić,Gerald G. Sander
Publsiher: Springer
Total Pages: 405
Release: 2019-08-02
Genre: Law
ISBN: 9783030164652

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This book gathers scientific contributions on comprehensive approaches to personalized medicine. In a systematic and clear manner, it provides extensive information on the methodological, technological, and clinical aspects of high-throughput analytics, nanotechnology approaches, microbiota/human interactions, in-vitro fertilization and preimplantation, and various diseases like cancer.Moreover, the book analyzes the social and legal aspects of social security systems, healthcare systems and EU law – e.g. the role of solidarity, regulatory possibilities and obstacles, justice and equality, privacy/disclosure of data, and the right to know – from an interdisciplinary perspective. Lastly, it explores the economical and ethical context in the fields of business models, intellectual property issues, the patient/physician relationship, and price discrimination.

The Challenges of Conducting Medical Device Studies

The Challenges of Conducting Medical Device Studies
Author: Keith Summerhayes
Publsiher: Inst of Clinical Research
Total Pages: 94
Release: 2005
Genre: Clinical trials
ISBN: 9780954934552

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Describing all the regulations, guidelines and directives that affect medical device studies.

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes
Author: Agency for Healthcare Research and Quality/AHRQ
Publsiher: Government Printing Office
Total Pages: 396
Release: 2014-04-01
Genre: Medical
ISBN: 9781587634338

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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.

Modern Methods of Clinical Investigation

Modern Methods of Clinical Investigation
Author: Institute of Medicine,Committee on Technological Innovation in Medicine
Publsiher: National Academies Press
Total Pages: 241
Release: 1990-02-01
Genre: Medical
ISBN: 9780309042864

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The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Assessing Medical Technologies

Assessing Medical Technologies
Author: Institute of Medicine,Division of Health Promotion and Disease Prevention,Division of Health Sciences Policy,Committee for Evaluating Medical Technologies in Clinical Use
Publsiher: National Academies Press
Total Pages: 592
Release: 1985-02-01
Genre: Medical
ISBN: 9780309035835

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New drugs, new devices, improved surgical techniques, and innovative diagnostic procedures and equipment emerge rapidly. But development of these technologies has outpaced evaluation of their safety, efficacy, cost-effectiveness, and ethical and social consequences. This volume, which is "strongly recommended" by The New England Journal of Medicine "to all those interested in the future of the practice of medicine," examines how new discoveries can be translated into better care, and how the current system's inefficiencies prevent effective health care delivery. In addition, the book offers detailed profiles of 20 organizations currently involved in medical technology assessment, and proposes ways to organize U.S. efforts and create a coordinated national system for evaluating new medical treatments and technology.