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eBook Clinical Evaluation of Medical Devices: Principles and Case Studies ePub

eBook Clinical Evaluation of Medical Devices: Principles and Case Studies ePub

by Karen Becker Witkin

  • ISBN: 0896034461
  • Category: Medicine and Health Sciences
  • Subcategory: Other
  • Author: Karen Becker Witkin
  • Language: English
  • Publisher: Humana Press; 1 edition (October 7, 1997)
  • Pages: 271
  • ePub book: 1886 kb
  • Fb2 book: 1955 kb
  • Other: lit docx txt azw
  • Rating: 4.7
  • Votes: 717

Description

the book is valuable and highly recommended. IFMBE News useful a. .

Principles and Case Studies. the book is valuable and highly recommended. Annals of the Royal College of Surgeons of England. Show all. Table of contents (19 chapters).

Additional case studies provide examples of combination products, three-phase development models (.

Автор: Witkin Karen Becker Название: Clinical Evaluation of Medical . This book will provide clinicians and students with theoretical and clinical guidelines to use the FRCs for dental applications. feasibility, FDA approval, and Medicare reimbursement), and novel study designs.

binabasa mo ang Clinical Evaluation of Medical Devices: Principles.

Clinical Evaluation of Medical Devices: Principles and Case Studies - Ebook na isinulat nina Karen Becker Witkin. Basahin ang aklat na ito gamit ang Google Play Books app sa iyong mga PC, android, at iOS device. I-download para sa pagbabasa offline, mag-highlight, mag-bookmark, o magsulat ng mga tala habang binabasa mo ang Clinical Evaluation of Medical Devices: Principles and Case Studies.

More than 20 years after the enactment of the US Medical Device Amendments, we can.

The purpose of Clinical Evaluation of Medical Devices: Principles and .

Karen M. Becker, John J. Whyte. Springer Science & Business Media, 5 нояб. Many small case studies are also included. The book has a comprehensive bibliography and a large appendix providing background analysis and computer subroutines of recently developed programs.

Many small case studies are also included.

Clinical evaluation of medical devices : principles and case studies. Part I. Fundamentals of Clinical Study Design and Evaluation. Foreword, Bert Spilker.

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.