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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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发表于 2025-3-21 16:54:42 | 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 Becker Witkin
视频videohttp://file.papertrans.cn/228/227947/227947.mp4
图书封面Titlebook: Clinical Evaluation of Medical Devices; Principles and Case  Karen Becker Witkin Book 1998 Springer Science+Business Media New York 1998 bi
描述The world is changing rapidly, and nowhere is this more apparent than in medicine. The standards are rapidly rising in the field of medical device trials. A few years ago, device developers would look askance if one told them that medical device trials and drug trials should have the same stan­ dards. Today, such a statement does not seem as outrageous, although there is still a large gap in the design of trials and number oftrials conducted for medical device and drug development programs. More than 20 years after the enactment of the US Medical Device Amendments, we can see that they served as an impetus to raise clinical trial standards for devices. Whether the data to establish the safety and efficacy of a device come from one, two, or even more clinical trials is less important in evaluating the device than whether the data are medically and scientifically support­ ive of its safety and efficacy. Having at least two separate studies, and at least two sites confirm results, adds a great deal of scientific credibility and support to a conclusion of safety and efficacy, even though a confirmatory trial is not yet a regulatory requirement in most countries.
出版日期Book 1998
关键词biodegradation; control; data analysis; design; development; diagnostics; hip arthroplasty; information; mar
版次1
doihttps://doi.org/10.1007/978-1-4757-2756-2
isbn_softcover978-1-61737-040-3
isbn_ebook978-1-4757-2756-2
copyrightSpringer Science+Business Media New York 1998
The information of publication is updating

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发表于 2025-3-21 22:05:50 | 显示全部楼层
Book 1998 and efficacy. Having at least two separate studies, and at least two sites confirm results, adds a great deal of scientific credibility and support to a conclusion of safety and efficacy, even though a confirmatory trial is not yet a regulatory requirement in most countries.
发表于 2025-3-22 00:43:10 | 显示全部楼层
its safety and efficacy. Having at least two separate studies, and at least two sites confirm results, adds a great deal of scientific credibility and support to a conclusion of safety and efficacy, even though a confirmatory trial is not yet a regulatory requirement in most countries.978-1-61737-040-3978-1-4757-2756-2
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Injectable Collagen and a Rare Adverse Event—True Association or Artifact?cal hypersensitivity response (1–2% of treated patients). Anecdotal reports received postmarketing suggested that injection of Zyderm/Zyplast implants may be associated with an increased risk of a rare autoimmune disease, polymyositis/dermatomyositis (PM/DM). In addition, a report by Cuckier et al.
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Clinical Studies of Prosthetic Heart Valves Using Historical Controlse been thoughtful design and engineering, carefully controlled manufacturing specifications, thorough laboratory pulse-duplicator and wear testing, animal implantation, and limited initial clinical use with thorough and complete hemodynamic and clinical follow-up.
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In Vitro Diagnosticsr its sequelae. Such products are intended for use in the collection, preparation and examination of specimens taken from the human body.”. Perhaps more simply defined, IVDs are laboratory instruments, test kits, or reagent systems.
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A Controlled Study of Intra-Articular Hyalgan® in the Treatment of Osteoarthritis of the Kneed and Drug Administration (FDA). However, this categorization may be questionable. Other regulatory authorities consider hyaluronic acid products as drugs because the mechanism of action appears to go beyond the mere physical function of replacing abnormal synovial fluid (“viscosupplementation”).
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Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves their first successful use approx 35 yr ago, both mechanical and tissue heart valve substitutes (. Fig. 1) remain imperfect, and prosthesis-associated complications have considerable impact on the long-term outlook for persons who have had valve replacement surgery.
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Polyurethane Pacemaker Leadsperformance of marketed products may be misleading if not done appropriately. Clinically based postmarket surveillance can reveal the true actuarial survival of a device and the clinical mode of failure. Analysis of returned products may be required to understand the details of failure mechanisms ..
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