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

痛恨

insolence

Hideo Tanaka,Kazutomi Sugihara,Yutaka Maedae 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.

圆柱

Studies in Fuzziness and Soft Computinge lengthy history and, as such, has been frequently—and at times inappropriately—used as a template for establishing standards for the conduct of orthopedic research. Both, however, share certain basic elements that are central to realizing good clinical research.

Coterminous

肉体

Categorical Innovations for Rough Setsd 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”).

变形词

Germinate

Hongyuan Shen,Shuren Yang,Jianxun Liuperformance 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 ..

chronicle

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 cond

的染料

Rough Set Methods and Applicationsed effect. As defined in the US Food, Drug and Cosmetic Act, the term medical device.This broad definition of medical devices encompasses literally tens of thousands of different types of health-care products, including in vitro diagnostics.

conjunctiva

Jerzy W. Grzymala-Busse,Rachel L. Freeman chapter will provide information on FDA regulatory requirements for controlled clinical investigations of medical devices and diagnostics, including who must conduct a clinical trial, the submissions required, and the procedures that must be followed.