Produktbild: Clinical Evaluation of Medical Devices
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Clinical Evaluation of Medical Devices Principles and Case Studies

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203,99 € UVP 235,39 €

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Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

15.12.2005

Abbildungen

360 p. 53 illus.

Herausgeber

Karen M. Becker + weitere

Verlag

Humana Press

Seitenzahl

360

Maße (L/B/H)

23,4/15,7/2,3 cm

Gewicht

703 g

Auflage

2nd ed. 2006

Sprache

Englisch

ISBN

978-1-58829-422-7

Beschreibung

Rezension

"Those preparing for or working on the development or clinical evaluation of a device will certainly find this book of value." -Respiratory Care


 


From Reviews of the First Edition...






"...provide[s] a wealth of useful information for those that are interested in conducting and evaluating clinical trials...highly recommended to the profession." -Biomaterials Forum






"...interesting and important reading for anybody who works in or with the medical device industry...to orthopedic surgeons in research or those who participate...in developing new devices. Several sections are of great value as an introduction and a supplement." -Acta Orthopaedica Scandinavica






"...useful as a supplement to courses on design of medical instrumentation, advanced design, biostatistics, and introductory physiology...will likely prove useful also as a reference text for practitioners in the field." -IEEE Engineering in Medicine and Biology






"...definitely fills a need for a description of principles and approaches to the clinical trials of medical devices... the book is valuable and highly recommended." -IFMBE News


"...useful as a reference book for those involved in the development of clinical trials..." - Annals of the Royal College of Surgeons of England

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

15.12.2005

Abbildungen

360 p. 53 illus.

Herausgeber

Verlag

Humana Press

Seitenzahl

360

Maße (L/B/H)

23,4/15,7/2,3 cm

Gewicht

703 g

Auflage

2nd ed. 2006

Sprache

Englisch

ISBN

978-1-58829-422-7

Herstelleradresse

Libri GmbH
Europaallee 1
36244 Bad Hersfeld
DE

Email: gpsr@libri.de

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  • Produktbild: Clinical Evaluation of Medical Devices
  • Fundamentals of Clinical Study Design and Evaluation.- Clinical Trials in Development and Marketing of Medical Devices.- Regulatory Requirements for Clinical Studies of Medical Devices and Diagnostics.- Requirements for Medicare Coverage and Reimbursement for Medical Devices.- Postmarket Requirements for Significant Risk Devices.- Applications of Bayesian Methods to Medical Device Trials.- Intellectual Property Protection for Medical Devices.- HIPAA Compliance in Clinical Research.- Overview of Medicare Coverage of Clinical Trials.- Developing Drug-Device Combination Products With Unapproved Components.- Wall Street’s Perspective on Medical Device Evaluation.- Case Studies.- Challenges in Conducting Implantable Device Trials.- BELIEF.- Clinical Trials of an Anti-Adhesion Adjuvant.- Use of Multiple Imputation Models in Medical Device Trials.- Case Studies on the Local Coverage Process.- Reimbursement Analysis.- Polyurethane Pacemaker Leads.- Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves.- The Use of Surrogate Outcome Measures.