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Titlebook: Clinical Evaluation of Medical Devices; Principles and Case Karen Becker Witkin Book 1998 Springer Science+Business Media New York 1998 bi

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楼主: invoke
发表于 2025-3-28 17:26:47 | 显示全部楼层
Rough Set Methods and Applications action. Unlike drugs, medical devices operate via physical or mechanical means and are not dependent on metabolism to accomplish their primary intended effect. As defined in the US Food, Drug and Cosmetic Act, the term medical device.This broad definition of medical devices encompasses literally te
发表于 2025-3-28 22:28:21 | 显示全部楼层
Lech Polkowski,Shusaku Tsumoto,Tsau Y. Liny and effectiveness, and constitutes the basis of the approval process for many medical devices.. One of the most important reasons why this method is preferred is that, through the randomization process, it is more likely to lead to an unbiased interpretation of results than other types of study de
发表于 2025-3-29 01:24:57 | 显示全部楼层
Rough Set Methods and Applicationsrs with guidelines for producing Premarket Approval Applications (PMAs) that contain scientific evidence for device safety and effectiveness.. Traditionally, clinical trials are recommended by the FDA for evaluation of the safety and effectiveness of diagnostic and/or therapeutic interventions. Clin
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发表于 2025-3-29 08:47:32 | 显示全部楼层
Hideo Tanaka,Kazutomi Sugihara,Yutaka Maeda with the natural history of heart valve disease. Experience has proven that acceptable replacement devices for diseased heart valves can be produced and evaluated clinically in single-arm studies, without using randomized or other concurrent controls. The elements of this successful development hav
发表于 2025-3-29 14:54:24 | 显示全部楼层
发表于 2025-3-29 19:38:26 | 显示全部楼层
https://doi.org/10.1007/978-3-540-89921-1plant can almost always be guaranteed substantial pain relief, greatly improved range of motion, and an improved quality of life. Unfortunately, many patients will, over time, experience a subsequent loosening of their prosthesis and a return of the clinical symptoms that led to the original arthrop
发表于 2025-3-29 22:30:46 | 显示全部楼层
P. Eklund,M. A. Galán,J. Karlsson long history of safe and effective use.. Zyderm® and Zyplast® implants are forms of injectable bovine collagen (highly purified bovine dermal collagen, containing at least 95% Type I and < 5% Type III collagen in a fibrillar suspension of physiologic buffered saline and 0.3% lidocaine). Injectable
发表于 2025-3-30 01:09:43 | 显示全部楼层
Rajen Bhatt,Sheela Ramanna,James F. Petersc Devices (IVDs). IVDs are, by definition of the Food and Drug Administration (FDA), “...those reagents, instruments and systems intended for use in the diagnosis of disease, or other conditions, including a determination of the state of health, in order to cure, mitigate, treat or prevent disease o
发表于 2025-3-30 04:37:49 | 显示全部楼层
Categorical Innovations for Rough Setsified hyaluronic acid (500–730 kDa), prepared as a buffered solution in physiologic saline. Hyalgan is injected intra-articularly for the sustained relief of pain and joint dysfunction in osteoarthritis of the knee. This product is classified as a device according to the current ruling of the US Foo
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