invoke 发表于 2025-3-21 16:54:42

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Metastasis 发表于 2025-3-21 22:05:50

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.

高原 发表于 2025-3-22 00:43:10

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

gain631 发表于 2025-3-22 07:54:32

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.

起来了 发表于 2025-3-22 11:58:32

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.

表示向前 发表于 2025-3-22 13:46:21

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表示向前 发表于 2025-3-22 18:47:37

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.

结合 发表于 2025-3-23 00:53:45

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”).

Brocas-Area 发表于 2025-3-23 04:08:56

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.

Phagocytes 发表于 2025-3-23 08:10:21

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