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Titlebook: Clinical Evaluation of Medical Devices; Principles and Case Karen M. Becker,John J. Whyte Book 2006Latest edition Humana Press 2006 Monito

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发表于 2025-3-21 17:40:44 | 显示全部楼层 |阅读模式
书目名称Clinical Evaluation of Medical Devices
副标题Principles and Case
编辑Karen M. Becker,John J. Whyte
视频video
概述Includes supplementary material:
图书封面Titlebook: Clinical Evaluation of Medical Devices; Principles and Case  Karen M. Becker,John J. Whyte Book 2006Latest edition Humana Press 2006 Monito
描述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- po
出版日期Book 2006Latest edition
关键词Monitor; Polyurethan; biodegradation; diagnostics; medical devices; technology assessment
版次2
doihttps://doi.org/10.1007/978-1-59745-004-1
isbn_softcover978-1-61737-558-3
isbn_ebook978-1-59745-004-1
copyrightHumana Press 2006
The information of publication is updating

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发表于 2025-3-21 21:10:52 | 显示全部楼层
Regulatory Requirements for Clinical Studies of Medical Devices and Diagnostics) Act.. Without the exemption, medical devices would have to comply with performance standard, premarket approval, or notification requirements to be lawfully shipped and used for investigational purposes.. Furthermore, itwould be exceedingly difficult—if not impossible—to conduct clinical trials fo
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Requirements for Medicare Coverage and Reimbursement for Medical Devices new technologies. By adopting long- and short-term strategies that incorporate these principles, manufacturers can avoid certain foreseeable delays in bringing devices to market. Although the roadmap for demonstrating to the Food and Drug Administration (FDA) the safety and efficacy of a device has
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HIPAA Compliance in Clinical Researchincreasingly difficult to conduct. Certainly, those involved in clinical research may feel frustrated or confused by HIPAA’s requirements, particularly when the media report that investigators have been denied access to patient records or that patient enrollment in studies has dramatically decreased
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Developing Drug-Device Combination Products With Unapproved Componentsues, companies are driven by the potential therapeutic success of combining two components into a single product. The driving force behind this new enthusiasm is the local delivery of drugs or biologics to a specific tissue, thereby minimizing the exposure of the whole body to potential toxic compou
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Wall Street’s Perspective on Medical Device Evaluationhis depends largely on its competitive advantage. In the medical device industry, success is categorically linked to new product flow, transitively marrying innovation and shareholder value creation. The medical device industry follows the punctuated equilibrium interpretation of Darwinism rather th
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