Clinical Evaluation Of Medical Devices

Author : Karen M. Becker,John J. Whyte
Publisher : Springer Science & Business Media
Page : 360 pages
File Size : 55,7 Mb
Release : 2007-11-05
Category : Technology & Engineering
ISBN : 9781597450041

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Clinical Evaluation of Medical Devices by Karen M. Becker,John J. Whyte Pdf

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.

Author : Karen Becker Witkin
Publisher : Unknown
Page : 286 pages
File Size : 50,6 Mb
Release : 2014-01-15
Category : Electronic
ISBN : 1475727577

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Clinical Evaluation of Medical Devices by Karen Becker Witkin Pdf

Author : Wolfgang Ecker,Gerold Labek,Tarquin Mittermayr,Brigitte Raffeiner,Michael Ring,Bernhard Schwartz
Publisher : BoD – Books on Demand
Page : 282 pages
File Size : 41,7 Mb
Release : 2020-06-04
Category : Medical
ISBN : 9783751937665

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Clinical Evaluation and Investigation of Medical Devices under the new EU-Regulation by Wolfgang Ecker,Gerold Labek,Tarquin Mittermayr,Brigitte Raffeiner,Michael Ring,Bernhard Schwartz Pdf

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.

Author : Keith Summerhayes
Publisher : Inst of Clinical Research
Page : 94 pages
File Size : 48,7 Mb
Release : 2005
Category : Clinical trials
ISBN : 9780954934552

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The Challenges of Conducting Medical Device Studies by Keith Summerhayes Pdf

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

Author : Institute of Medicine,Division of Health Promotion and Disease Prevention,Division of Health Sciences Policy,Committee for Evaluating Medical Technologies in Clinical Use
Publisher : National Academies Press
Page : 592 pages
File Size : 54,5 Mb
Release : 1985-02-01
Category : Medical
ISBN : 9780309035835

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Assessing Medical Technologies by Institute of Medicine,Division of Health Promotion and Disease Prevention,Division of Health Sciences Policy,Committee for Evaluating Medical Technologies in Clinical Use Pdf

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.

Author : Joy Frestedt
Publisher : Elsevier
Page : 0 pages
File Size : 50,6 Mb
Release : 2024-06-01
Category : Computers
ISBN : 9780443220647

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Planning, Writing and Reviewing Medical Device Clinical and Performance Evaluation Reports (CERs/PERs) by Joy Frestedt Pdf

A Practical Guide to Planning, Writing, and Reviewing Medical Device Clinical Evaluation Reports guides readers through clinical data evaluation of medical devices, in compliance with the EU MDR requirements and other similar regulatory requirements throughout the world. This book brings together knowledge learned as the author constructed hundreds of CERs and taught thousands of learners on how to conduct clinical data evaluations. This book will support training for clinical engineers, clinical evaluation scientists, and experts reviewing medical device CERs, and will help individual writers, teams and companies to develop stronger, more robust CERs. Identifies and explains data analysis for clinical evaluation of medical devices Teaches readers how to understand and evaluate medical device performance and safety in the context of new regulations Provides analysis of new clinical evaluation criteria in the context of medical device design as well as in-hospital deployment and servicing

Author : G.R Higson
Publisher : CRC Press
Page : 278 pages
File Size : 42,7 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 : Peter J Ogrodnik
Publisher : Academic Press
Page : 376 pages
File Size : 54,6 Mb
Release : 2012-12-17
Category : Technology & Engineering
ISBN : 9780123919434

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Medical Device Design by Peter J Ogrodnik Pdf

This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Author : Shalinee Naidoo
Publisher : Arcler Press
Page : 0 pages
File Size : 43,8 Mb
Release : 2022-12
Category : Electronic
ISBN : 177469414X

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Clinical Evaluations for Medical Devices by Shalinee Naidoo Pdf

Being a medical device manufacturer involves more than just manufacturing of the device itself. It is also the manufacturers responsibility to ensure adequate research is done on the device so that it can be safely used. Clinical evidence is often collected throughout the entire life cycle of a medical device and is often an ongoing process. The process starts during the design and development of the device to show safety and efficacy and is often updated even after the device is on the market. This evidence is often compiled in a Clinical Evaluation Report and presents itself a chapter of the device technical file. As the medical industry continues to evolve, so does the complexity of clinical data needed during the regulatory approval process. This volume provides an introduction into the basic concepts of clinical evaluation report writing. Important concepts such as how to conduct a literature review, claiming equivalence and when to update your clinical reports are covered.

Author : Nada Bodiroga-Vukobrat,Daniel Rukavina,Krešimir Pavelić,Gerald G. Sander
Publisher : Springer
Page : 405 pages
File Size : 44,7 Mb
Release : 2019-08-02
Category : Law
ISBN : 9783030164652

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Personalized Medicine in Healthcare Systems by Nada Bodiroga-Vukobrat,Daniel Rukavina,Krešimir Pavelić,Gerald G. Sander Pdf

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.

Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 49,8 Mb
Release : 1990-02-01
Category : Medical
ISBN : 9780309042864

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Modern Methods of Clinical Investigation by Institute of Medicine,Committee on Technological Innovation in Medicine Pdf

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.

Author : Jack Wong,Raymond K. Y. Tong
Publisher : CRC Press
Page : 620 pages
File Size : 54,7 Mb
Release : 2022-01-27
Category : Medical
ISBN : 9781000440539

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Medical Regulatory Affairs by Jack Wong,Raymond K. Y. Tong Pdf

This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Author : Annetine C. Gelijns
Publisher : National Academies
Page : 78 pages
File Size : 47,9 Mb
Release : 1989
Category : Clinical medicine
ISBN : NAP:13516

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Technological Innovation by Annetine C. Gelijns Pdf

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
Page : 396 pages
File Size : 50,8 Mb
Release : 2014-04-01
Category : Medical
ISBN : 9781587634338

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Registries for Evaluating Patient Outcomes by Agency for Healthcare Research and Quality/AHRQ Pdf

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.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
Publisher : National Academies Press
Page : 442 pages
File Size : 47,5 Mb
Release : 2011-04-03
Category : Medical
ISBN : 9780309158060

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Rare Diseases and Orphan Products by Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development Pdf

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.