標(biāo)題: Titlebook: Clinical Evaluation of Medical Devices; Principles and Case Karen M. Becker,John J. Whyte Book 2006Latest edition Humana Press 2006 Monito [打印本頁(yè)] 作者: 銀河 時(shí)間: 2025-3-21 17:40
書(shū)目名稱Clinical Evaluation of Medical Devices影響因子(影響力)
書(shū)目名稱Clinical Evaluation of Medical Devices影響因子(影響力)學(xué)科排名
書(shū)目名稱Clinical Evaluation of Medical Devices網(wǎng)絡(luò)公開(kāi)度
書(shū)目名稱Clinical Evaluation of Medical Devices網(wǎng)絡(luò)公開(kāi)度學(xué)科排名
書(shū)目名稱Clinical Evaluation of Medical Devices被引頻次
書(shū)目名稱Clinical Evaluation of Medical Devices被引頻次學(xué)科排名
書(shū)目名稱Clinical Evaluation of Medical Devices年度引用
書(shū)目名稱Clinical Evaluation of Medical Devices年度引用學(xué)科排名
書(shū)目名稱Clinical Evaluation of Medical Devices讀者反饋
書(shū)目名稱Clinical Evaluation of Medical Devices讀者反饋學(xué)科排名
作者: 老人病學(xué) 時(shí)間: 2025-3-21 21:10
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作者: 離開(kāi)可分裂 時(shí)間: 2025-3-22 00:29
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作者: 虛弱的神經(jīng) 時(shí)間: 2025-3-22 07:07 作者: 難解 時(shí)間: 2025-3-22 11:17 作者: consent 時(shí)間: 2025-3-22 16:36
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作者: consent 時(shí)間: 2025-3-22 19:43 作者: 勾引 時(shí)間: 2025-3-22 23:42
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作者: browbeat 時(shí)間: 2025-3-23 05:19
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作者: 入會(huì) 時(shí)間: 2025-3-23 07:04 作者: 平靜生活 時(shí)間: 2025-3-23 10:18
BELIEFnary artery bypass grafting (CABG). There is, however, a growing number of patients who have medically refractory angina caused by diffuse coronary artery disease who are not eligible for PCI or CABG owing to diffuse, distal disease.. Treatment options are limited for this subset of patients.作者: 令人不快 時(shí)間: 2025-3-23 15:02
Clinical Trials of an Anti-Adhesion Adjuvantf the frequency with which they form, as well as their consequences of potential morbidity and mortality.. Yet, many surgeons minimize their significance because of the general inability to identify adhesions without performing a repeat surgery, as there are not good serologic markers or accurate im作者: Notorious 時(shí)間: 2025-3-23 19:50
Use of Multiple Imputation Models in Medical Device Trialsvalues, is an intuitive and flexible way to handle the incomplete data sets that arise because of such missing data. Here we present several imputation strategies and their theoretical background, as well as some current examples and advice on computation. Our focus is on multiple imputation, which 作者: Presbyopia 時(shí)間: 2025-3-23 23:36 作者: NOCT 時(shí)間: 2025-3-24 02:31 作者: tolerance 時(shí)間: 2025-3-24 06:54 作者: 油膏 時(shí)間: 2025-3-24 14:31 作者: Exhilarate 時(shí)間: 2025-3-24 18:04 作者: 分開(kāi) 時(shí)間: 2025-3-24 20:36 作者: Lipoma 時(shí)間: 2025-3-24 23:50
https://doi.org/10.1007/978-3-319-29052-2the Medicare program, (2) the creation of stakeholder partnerships, and (3) the need to properly use medical evidence. Most coverage policies represent a combination of these forces. In fact, there is only the occasional local coverage scenario, which is characterized by the pure expression of any solitary element.作者: 怒目而視 時(shí)間: 2025-3-25 07:12 作者: 大廳 時(shí)間: 2025-3-25 08:12 作者: 人類 時(shí)間: 2025-3-25 11:55
https://doi.org/10.1007/978-3-031-08530-7t of useful devices for human use”. and “to protect the public health by requiring safeguards for human subjects of investigations, sound ethical standards, and procedures to assure development of reliable scientific data.”作者: 圓錐體 時(shí)間: 2025-3-25 16:45
Gongtian Shen,Zhanwen Wu,Junjiao Zhangost importantly, this 2- to 5-years anticipated timeframe for coverage can be reduced if a reimbursement plan is implemented early in product development. When developing a reimbursement plan, companies should address the following questions, preferably while their product is still in the development phase:作者: 情感脆弱 時(shí)間: 2025-3-25 21:29
Regulatory Requirements for Clinical Studies of Medical Devices and Diagnosticst of useful devices for human use”. and “to protect the public health by requiring safeguards for human subjects of investigations, sound ethical standards, and procedures to assure development of reliable scientific data.”作者: 細(xì)頸瓶 時(shí)間: 2025-3-26 01:08 作者: 帶子 時(shí)間: 2025-3-26 07:05 作者: Strength 時(shí)間: 2025-3-26 11:20 作者: 討人喜歡 時(shí)間: 2025-3-26 14:30
vided 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作者: PRISE 時(shí)間: 2025-3-26 17:09 作者: ureter 時(shí)間: 2025-3-26 22:21 作者: heterodox 時(shí)間: 2025-3-27 04:19 作者: 一回合 時(shí)間: 2025-3-27 08:49
Case Studies on the Local Coverage Processthe Medicare program, (2) the creation of stakeholder partnerships, and (3) the need to properly use medical evidence. Most coverage policies represent a combination of these forces. In fact, there is only the occasional local coverage scenario, which is characterized by the pure expression of any solitary element.作者: 網(wǎng)絡(luò)添麻煩 時(shí)間: 2025-3-27 11:38 作者: 北極人 時(shí)間: 2025-3-27 14:18 作者: 充足 時(shí)間: 2025-3-27 18:28
Postmarket Requirements for Significant Risk Devicesessary) against medical devices after they have gone to market. This chapter provides an overview of the various postmarket requirements that can be imposed on manufacturers, importers, distributors, and device-user facilities.作者: 放肆的你 時(shí)間: 2025-3-27 22:32
Intellectual Property Protection for Medical DevicesP includes discoveries, inventions, technological advancement or development, literary or artistic works, and unique names for trade or business. A concise summary of the available IP tools appears in Table 1.作者: 河潭 時(shí)間: 2025-3-28 05:37
Challenges in Conducting Implantable Device Trialsce the life expectancy and quality of life of patients. With changes in US Food and Drug Administration (FDA) regulatory policies and increased demand for more rigorous clinical evidence by payors, physicians, and patients alike, there has been more emphasis on randomized trials to evaluate new devices as they move from bench to bedside.作者: RAFF 時(shí)間: 2025-3-28 09:40 作者: Ethics 時(shí)間: 2025-3-28 12:03
Yuxi Liu,Shaowen Qin,Zhenhao Zhang, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect.As defined in the federal Food, Drug, and Cosmetic (FD&C) Act, the term .:作者: 使尷尬 時(shí)間: 2025-3-28 16:24 作者: extract 時(shí)間: 2025-3-28 22:14
https://doi.org/10.1007/978-3-540-72135-2 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作者: 慎重 時(shí)間: 2025-3-28 23:19 作者: Basilar-Artery 時(shí)間: 2025-3-29 03:57 作者: Parameter 時(shí)間: 2025-3-29 11:11 作者: 僵硬 時(shí)間: 2025-3-29 12:09 作者: 售穴 時(shí)間: 2025-3-29 19:27 作者: GRATE 時(shí)間: 2025-3-29 19:55 作者: 鋪?zhàn)?nbsp; 時(shí)間: 2025-3-30 03:08
Advances in Acoustic Emission Technologyce the life expectancy and quality of life of patients. With changes in US Food and Drug Administration (FDA) regulatory policies and increased demand for more rigorous clinical evidence by payors, physicians, and patients alike, there has been more emphasis on randomized trials to evaluate new devi作者: COMA 時(shí)間: 2025-3-30 07:51 作者: 邪惡的你 時(shí)間: 2025-3-30 08:41
UNISCOPE: Instrument Integrating NDT Methodsf the frequency with which they form, as well as their consequences of potential morbidity and mortality.. Yet, many surgeons minimize their significance because of the general inability to identify adhesions without performing a repeat surgery, as there are not good serologic markers or accurate im作者: anus928 時(shí)間: 2025-3-30 15:52 作者: DECRY 時(shí)間: 2025-3-30 17:36
https://doi.org/10.1007/978-3-319-29052-2 coverage process, there is considerable value in presenting a more global, integrated approach. There are three major defining forces, which provide such a framework, and can be further exemplified by selected recent coverage case studies. These three forces are (1) specific regulatory mandates of 作者: ETHER 時(shí)間: 2025-3-30 21:59 作者: expeditious 時(shí)間: 2025-3-31 04:03 作者: 無(wú)目標(biāo) 時(shí)間: 2025-3-31 05:34
Karen M. Becker,John J. WhyteIncludes supplementary material: 作者: 周年紀(jì)念日 時(shí)間: 2025-3-31 12:49
http://image.papertrans.cn/c/image/227946.jpg作者: disciplined 時(shí)間: 2025-3-31 13:42
https://doi.org/10.1007/978-1-59745-004-1Monitor; Polyurethan; biodegradation; diagnostics; medical devices; technology assessment作者: 爵士樂(lè) 時(shí)間: 2025-3-31 19:49
Yuxi Liu,Shaowen Qin,Zhenhao Zhang, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect.As defined in the federal Food, Drug, and Cosmetic (FD&C) Act, the term .:作者: EXCEL 時(shí)間: 2025-4-1 01:37 作者: aplomb 時(shí)間: 2025-4-1 02:42 作者: 陳腐的人 時(shí)間: 2025-4-1 06:31
Advances in Acoustic Emission Technologyce the life expectancy and quality of life of patients. With changes in US Food and Drug Administration (FDA) regulatory policies and increased demand for more rigorous clinical evidence by payors, physicians, and patients alike, there has been more emphasis on randomized trials to evaluate new devices as they move from bench to bedside.
