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Download e-book for iPad: Clinical Evaluation of Medical Devices: Principles and Case by Karen M. Becker,John J. Whyte

By Karen M. Becker,John J. Whyte

ISBN-10: 1588294226

ISBN-13: 9781588294227

ISBN-10: 1617375586

ISBN-13: 9781617375583

the unique variation of this article, scientific review of clinical units: ideas and Case reports, supplied the 1st assessment of key pr- ciples and techniques to clinical gadget medical trials, illustrated with a chain of distinctive, real-world case reports. The e-book is designed as a source for scientific execs and regulatory experts operating within the box of recent clinical gadget improvement and advertising. because the first variation of this article used to be released in 1997, the quick velocity of inno- tion in wellbeing and fitness care applied sciences keeps to yield fascinating and significant new items. The regulatory panorama has additionally advanced, reflecting many of the adjustments and wishes in the scientific gadget undefined. the aim of medical evaluate of scientific units: ideas and Case experiences, moment variation is to supply an up-to-date and accelerated presentation of the clinical tools and regulatory necessities utilized to the examine of latest major threat scientific units. The textual content now comprises (1) new info at the specifications and procedure for gaining repayment of recent items from Medicare and personal insurers, with case reports of analysis particularly designed for this p- pose in addition to health and wellbeing care know-how overview tools; (2) infor- tion on new statistical methodologies utilized to scientific equipment trials; and (3) all new case experiences, together with examples of mix pr- ucts, three-phase improvement versions (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel learn designs.

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Clinical Evaluation of Medical Devices: Principles and Case Studies by Karen M. Becker,John J. Whyte


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